Denise Myshko is your editorial contact for the Formulary Watch. She joined Formulary Watch as editor is June 2021 from Oncology Live. Prior to that, she was managing editor of PharmaVOICE, a trade publication in the pharmaceutical industry. Email: dmyshko@mjhlifesciences.com

 its new drug application (NDA) to FDA for lenacapavir for the treatment of patients with HIV-1 infection in heavily treatment-experienced patients.

“There are people with HIV who have severely limited treatment options due to resistance to multiple antiretroviral therapy classes,” Jared Baeten, M.D., Ph.D., vice president, HIV clinical development, Gilead Sciences, said in a press release.

 a complete response letter (CRL) for lenacapavir, citing chemistry manufacturing and controls (CMC) issues relating to the compatibility of lenacapavir with the proposed container vial. In December 2021, the FDA had placed a clinical hold on trials with lenacapavir. The agency had raised questions about vials made of borosilicate glass and their compatibility with lenacapavir solution. The concern was about the possibility of glass particles forming in the solution of lenacapavir.

The resubmission contains CMC data to support the compatibility of lenacapavir with an alternative vial type made from aluminosilicate glass

The NDA is supported by data from the phase 2/3 CAPELLA study, which evaluated the antiviral activity of lenacapavir administered every six months as a subcutaneous injection. The trial showed that, based on week 26 data, lenacapavir achieved high rates of virologic suppression in heavily treatment-experienced people with HIV.

Lenacapavir is a first-in-class, investigational long-acting HIV-1 capsid inhibitor. s designed to inhibit HIV-1 at multiple stages of its lifecycle and has no known cross resistance to other existing drug classes. If approved, lenacapavir would be the only HIV-1 treatment option administered twice-yearly.

 at the 29th Conference on Retroviruses and Opportunistic Infections from the CAPELLA trial. The data were also 

The trial showed that lenacapavir, administered subcutaneously every six months in combination with other antiretrovirals, achieved high rates of virologic suppression and clinically meaningful increases in CD4 counts in people living with HIV whose virus was no longer effectively responding to their current therapy. In the CAPELLA study, the most common adverse events observed were injection site reactions (63%), nausea and diarrhea (13% each), and COVID-19 (11%).

In Europe, lenacapavir recently received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The CHMP positive opinion will be reviewed by the European Commision, which has the authority to authorize medicines in the 27 Member States of the European Union, as well as Norway, Iceland and Liechtenstein. The final European Commission decision is expected later this year.

Articles

If approved, lenacapavir would be the first HIV-1 treatment administered twice-yearly.

Gilead Resubmits NDA of Long-Acting Lenacapavir for HIV

Biogen is terminating its observational, post-marketing trial of Aduhlem (aducanumab-avwa) because the company expects limited usage of the Alzheimer’s disease medication.

“As a result of the national policy for coverage, it is expected there will be limited aducanumab-avwa prescription and usage in routine clinical practice, making the study not feasible for enrollment,” Biogen posted in a June 21 

A spokesperson for Biogen said the pharmaceutical manufacturer did not want to provide additional comments or information on the decision.

 that Medicare will only cover Aduhelm for patients in specific clinical trials. In its final Medicare national coverage determination (NCD), 

 FDA-approved monoclonal antibodies to treat Alzheimer’s disease may only be covered in a randomized, controlled trial conducted under an investigational new drug application.

The trial being cancelled is a prospective, single-arm, multicenter, non-interventional study of aducanumab-avwa compared with standard of care. Participants would have followed up to five years after enrollment.

Biogen is, however, currently recruiting patients for its confirmatory phase 4 trial. The 

 study is a randomized, placebo controlled trial that aims to verify the benefit of Aduhelm in patients with early Alzheimer’s disease. It is a requirement based on FDA’s accelerated approval of Aduhelm. The primary endpoint for the trial will be measured by the Clinical Dementia Rating–Sum of Boxes (CDR-SB) at 18 months. The trial will also include a planned long-term extension to collect treatment data for up to 48 months.

Additionally, because of the CMS decision, Biogen 

 that it would “substantially eliminate its commercial infrastructure supporting Aduhelm, retaining minimal resources to manage patient access programs, including a continued free drug program for patients currently on treatment in the United States.”

In addition, Biogen CEO Michel Vounatsos agreed to step down.

In early May, UnitedHealthcare said in an updated 

 that patients taking Aduhelm must be in an approved clinical trial. The drug is “unproven and not medically necessary for the treatment of Alzheimer’s disease due to insufficient evidence of efficacy.”

The trial was an observational study aimed at collecting real-world data on the Alzheimer’s treatment.

Biogen Terminates Aduhelm Clinical Trial 

 PANTHERx Rare as the exclusive U.S. pharmacy distribution partner for Diacomit (stiripentol), which is available for the adjunctive treatment of seizures associated with Dravet syndrome in those 2 years of age and older taking clobazam. It is delivered as oral capsules or powder for oral suspension. The FDA had approved the therapy in August 2018.

Dravet syndrome, also known as severe myoclonic epilepsy infancy, is a rare epileptic disorder typically diagnosed in infancy occurring in 1 in 15,700 people in the United States. It is often characterized by temperature-sensitive seizures and febrile seizures that may be difficult to treat. The majority of infants with Dravet syndrome have a genetic mutation in the SCN1A gene. Dravet syndrome is a lifelong disorder that can be associated with severe complications and decreased quality of life. The mortality rate ranges from 3.7% to 17.5% with 15% and 61% of deaths attributed to sudden unexpected death in epilepsy.

"Our partnership will allow the Dravet syndrome community renewed hope for improved health outcomes,” Rob Snyder, president of PANTHERx, said in a press release. “We look forward to assisting the members of this rare patient population as they navigate their health journeys.”

Diacomit was approved in 2018 for seizures associated with Dravet syndrome, a rare pediatric disorder.

Biocodex Selects PANTHERx as New Distributor for Diacomit

The FDA has updated the safety labels of all products that contain buprenorphine to warn about the risks of dental disease and QT prolongation resulting from the use of these products. Buprenorphine is used to treat opioid use disorder and pain. These products are available as single-ingredient products and also in combination with naloxone.

The updates have been made to ensure all labels for buprenorphine products are consistent. This includes all generics as well as branded therapies, such as Belbuca, Buprenex, Suboxone, Zubsolv, and among others.

The QT interval is a measure made on an electrocardiogram and is used to assess the electrical properties of heart. Long QT can cause rapid heart rate and irregular rhythm and can be life-threatening.

The agency’s action for ensuring all labels warn of QT prolongation is supported by several studies, including a November 2020 study 

 in PLoS ONE. Previous studies with buprenorphine products have demonstrated a small QT prolongation effect. The label addition indicates that buprenorphine alone is unlikely to cause serious issues in patients without risk factors, such as low potassium, low heart rate, congestive heart failure, digitalis therapy, baseline QT prolongation, or severe low magnesium.

“Thorough QT studies with buprenorphine products have demonstrated QT prolongation less than or equal to 15 msec. This QTc prolongation effect does not appear to be mediated by hERG channels. Based on these two findings, buprenorphine is unlikely to be pro-arrhythmic when used alone in patients without risk factors. The risk of combining buprenorphine with other QT-prolonging agents is not known.

“Consider these observations in clinical decisions when prescribing … to patients with risk factors such as hypokalemia, bradycardia, recent conversion from atrial fibrillation, congestive heart failure, digitalis therapy, baseline QT prolongation, subclinical long-QT syndrome, or severe hypomagnesemia.”

 about the dental problems associated with buprenorphine products that dissolve in the mouth. These include tooth decay, cavities, oral infections, and loss of teeth and can be serious. These issues have been reported even in patients with no history of dental issues. The FDA has not identified a concern with buprenorphine products delivered by skin patch and injection.

Buprenorphine was approved in 2002 as a tablet to be administered under the tongue to treat opioid use disorder. In 2015, buprenorphine was approved as a film to be placed inside the cheek to treat pain.

The use of buprenorphine-containing medicines that are dissolved in the mouth has been growing. The estimated number of prescriptions dispensed from U.S. outpatient retail and mail-order pharmacies increased from 11 million in 2014 to 16 million in 2020, according to information provided by the FDA.

Regulators have identified 305 cases of dental problems (131 cases classified as serious) with buprenorphine medicines dissolved in the mouth. Most cases were in patients using the medicines for opioid use disorder; but 28 cases of dental problems occurred in patients using it to treat pain. In 26 cases, patients had no prior history of dental problems. Some cases reported dental problems occurring as soon as two weeks after treatment began, with the median time to diagnosis being about two years after starting treatment.

The most common treatment for these dental problems was tooth extraction/removal, which was reported in 71 cases. Other cases reported requiring root canals, dental surgery, and other procedures such as crowns and implants.

The new subsection on dental adverse events now reads:

“Cases of dental caries, some severe (i.e., tooth fracture, tooth loss), have been reported following the use of transmucosal buprenorphine-containing products. Reported events include cavities, tooth decay, dental abscesses/infection, rampant caries, tooth erosion, fillings falling out, and, in some cases, total tooth loss. Treatment for these events included tooth extraction, root canal, dental surgery, as well as other restorative procedures (i.e., fillings, crowns, implants, dentures). Multiple cases were reported in individuals without any prior history of dental problems.”

Labels now warn that buprenorphine products that dissolve in the mouth can cause dental problems. Buprenorphine is used to treat opioid use disorder and pain.

FDA Updates Safety Labels of Buprenorphine Products

 Breyanzi (lisocabtagene maraleucel) for the treatment of adult patients with large B-cell lymphoma (LBCL) after one prior therapy. Developed by Bristol Myers Squibb, Breyanzi is a CD19-directed chimeric antigen receptor (CAR) T-cell therapy. Breyanzi was previously approved by the FDA for the treatment of adult patients with relapsed or refractory LBCL after two or more lines of systemic therapy.

“Patients with large B-cell lymphoma whose disease does not respond to or relapses after first-line therapy often face lengthy and intensive cycles of chemotherapy with the goal of proceeding to stem cell transplant,” Lee Greenberger, Ph.D., chief scientific officer of the Leukemia & Lymphoma Society, said in a press release.

Large B-cell lymphoma is a difficult-to-treat and aggressive blood cancer, and up to 40% of patients have disease that is refractory to or relapses after initial therapy. Standard of care is stem cell transplant. But half of patients are not considered candidates for a hematopoietic stem cell transplant due to age and/or comorbidities, and only an estimated 25% of those who are candidates are able to receive a stem cell transplant and experience long-term clinical benefit.

In the pivotal phase 3 TRANSFORM trial, a single infusion of Breyanzi had median event-free survival of 10.1 months vs. 2.3 months for stem cell transplant. Approval was also based on data from the phase 2 PILOT study of a CAR T-cell therapy in patients with primary refractory or relapsed LBCL who are not considered candidates for transplant.

In the TRANSFORM study, the majority of patients achieved a complete response with Breyanzi compared with less than half with standard therapy. In the PILOT study, Breyanzi achieved an overall response rate of 80%, the study’s primary endpoint, and a complete response rate of 54%. Median duration of response was 11.2 months.

Occurrences of cytokine release syndrome and neurologic events were generally low grade and mostly resolved quickly, and without the use of prophylactic steroids. Any-grade cytokine release syndrome was reported in less than half of patients (45%), with grade 3 cytokine release syndrome reported in 1.3% of patients. Any-grade neurologic events were reported in 27%, with grade 3 neurologic events reported in 7% of patients.

Breyanzi is available through a restricted Risk Evaluation and Mitigation Strategy (REMS) program. The REMS program requires Breyanzi to be dispensed in enrolled healthcare facilities with providers who are trained in the management of cytokine release syndrome and neurologic toxicities.

Breyanzi is now available as a second-line treatment for this aggressive blood cancer.

FDA Approves Breyanzi for Additional Indication in Large B-Cell Lymphoma

A new FDA proposed role would broaden the range of over-the-counter medications for consumers, the agency said in a 

Nonprescription Drug Product with an Additional Condition for Nonprescription Use

 proposal would expand options for consumers by establishing the requirements for a drug company that submits a new application to bring a nonprescription drug product to market.

When the FDA finds that labeling alone is not sufficient to ensure that the consumer can appropriately self-select and use a drug product in a nonprescription setting, a pharmaceutical manufacturer may submit an application proposing an additional condition for nonprescription use that a consumer must successfully fulfill to obtain the nonprescription drug product.

“Nonprescription drug products play a vital role in America’s healthcare system, as millions of people use them to self-manage health conditions every day,” FDA Commissioner Robert M. Califf, M.D., said in a press release. “As part of the FDA’s ongoing efforts to improve public health, this proposal can broaden the types of drugs that can be approved as nonprescription—increasing availability of drugs that would otherwise only be available by prescription.”

The cost savings of having the prescription drugs available OTC is significant.

The FDA estimates the primary cost savings to consumers would be $26,70 per product, with a range of $0 to $53.40 per consumer per purchase, the agency said in the proposed rule. “There may also be cost savings associated with a potential reduction in the number of repetitive meetings between FDA and industry. Our primary estimate is $55,469 per applicant with a range of $45,260 to $66,174.”

Government and private insurance payers may also realize cost savings because the availability of nonprescription drug products with an Additional Condition for Non-Prescription Use (ACNU) may decrease future medical costs and the number of submitted insurance claims, according to the FDA.

The manufacturer applying for the non-prescription use must “ensure appropriate self-selection or appropriate actual use, or both, by consumers of the nonprescription drug product,” the FDA said.

For example, an applicant could propose an additional condition for nonprescription use that requires a consumer to respond with specific answers to a set of questions on a self-selection test available by either a phone app or an automated telephone response system in order to purchase the nonprescription drug product.

“Under the proposed rule, if the FDA finds that the additional condition for nonprescription use will permit appropriate self-selection and/or appropriate actual use of the product, and consumers can use the product safely and effectively without the supervision of a healthcare practitioner, it may approve the product for nonprescription use with the additional condition for nonprescription use,” the agency said.

The FDA is accepting comments on the proposed rule through Oct. 26, 2022.

New FDA Proposal Would Make Adding OTC Approval to Prescription Drugs Easier

Sanofi is the latest pharmaceutical company to lower the price of insulin. Effective July 1, 2022, Sanofi has lowered the out-of-pocket cost of its insulins to $35 for a 30-day supply through the company’s Insulins 

 Savings Program. Previously, the program offered its insulins for $99. This includes Toujeo (insulin glargine), Lantus (insulin glargine), Admelog (insulin lispro), and Apidra (insulin glulisine). The program does not include Sanofi combination insulin product Soliqua (insulin glargine and lixisenatide). The program is open to anyone regardless of income.

Sanofi also recently launched Insulin Glargine Injection U-100 at a price that is 60% less than the current Lantus list price.

“Informed by patient feedback, Sanofi has updated our industry-leading assistance program to continue addressing access and affordability challenges for all people living with diabetes, regardless of insurance coverage,” Adam Gluck, head of U.S. and Global Specialty Care Corporate Affairs at Sanofi, said in a 

Other pharmaceutical companies lowering the cost of insulins include Lilly and Novo Nordisk.In September 2021, Lilly 

 that it was lowering the list price of Insulin Lispro Injection in the U.S. by an additional 40 percent effective Jan. 1, 2022. Those using Lilly insulins can now fill their monthly prescription for $35 through the Lilly Insulin Value Program for people with commercial insurance or who are uninsured, and the Senior Savings Model for seniors in participating Medicare Part D plans.
Novo Nordisk also 

 lower cost insulins, including a 30-day supply of a combination of Novo Nordisk insulin products (up to three vials or two packs of pens) for $99 for eligible patients. Additionally, Novo Nordisk human insulin is available at national pharmacies like Walmart and CVS for about $25 per vial.

In additional to the lowering out-of-pocket costs for insulin, Sanofi offers co-pay assistance programs, regardless of income or insurance plan design, which limits out-of-pocket expenses for a majority of people between $0 and $10. Sanofi is also a part of the Centers for Medicare and Medicaid Services’ (CMS) Senior Savings Model, which allows patients enrolled in participating Part D plans to pay a $35 or less co-pay for each 30-day prescription of a Sanofi insulin throughout the year.

A $35 cap on insulin is popular. About 87% of voters 

 by think tank Data for Progress support the idea.

Out-of-pocket prices for insulin continue to be high and are rising. The average cash price for insulins climbed about 54% from 2014 to 2019 from $0.22 to $0.34 per insulin unit, according to 

. Since then, it dropped 5% from about $0.33 to $0.31. An insulin unit is a measure used for dosing. For example, a concentration of U-100 has 100 insulin units per milliliter.

Most of this decline is a result of recent approvals of generics and biosimilars. But not all insulins saw decreases, according to GoodRx’s January 2022 report on insulins. The organization tracked 28 insulins across all manufacturers and insulin types. A package of five generic insulin lispro KwikPens, for example, still costs about $300, compared with the $700 price for a similar package of Humalog KwikPens.

Congressional efforts continue to aim to address these high costs. Most recently, U.S. Senators Susan Collins (R-ME) and Jeanne Shaheen (D-NH), co-chairs of the Senate Diabetes Caucus, 

 new bipartisan legislation, the Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act.

This proposed legislation builds on their previous efforts and would make insulins eligible for cost-sharing protections, including a waiver of any applicable deductible and limiting copays or coinsurance to no more than $35 per month or 25% of list price. It would ensure that insurance plans and PBMs cannot collect rebates on insulins that limit list price to the 2021 net prices for Medicare Part D or equivalent levels.

Sanofi has lowered the out-of-pocket cost of its insulins to $35 for a 30-day supply through the company’s savings program.

Sanofi Lowers Insulin Price

 for review the Eylea (aflibercept) injection supplemental biologics license application (sBLA) for an every 16-week 2 mg dosing regimen in patients with diabetic retinopathy. The target action date for the FDA decision is Feb. 28, 2023.

Eylea is a VEGF inhibitor that is injected into the eye. It is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels in the eye by blocking VEGF-A and placental growth factor. In 2019, the FDA approved Eylea for the treatment of all stages of diabetic retinopathy with a dosing regimen of every four or eight weeks after five initial monthly doses. Eylea is also approved for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion and diabetic macular edema.

The supplemental application is supported by data from the phase 3 

 trial investigating every 8- and 16-week Eylea dosing regimens, versus sham, in patients with severe non-proliferative diabetic retinopathy without diabetic macular edema. The submission was further supported by data from the NIH-sponsored 

 trial investigating Eylea every 16-week dosing regimen in patients with moderate-to-severe non-proliferative diabetic retinopathy without center-involved DME versus sham.

At one year, the PANORAMA trial met its primary endpoint of proportion of patients with ≥2-step improvement in Diabetic Retinopathy Severity Scale (DRSS) score. At two years, in both studies, a greater proportion of patients receiving Eylea every 16-weeks experienced a ≥2-step improvement in DRSS score, along with greater reductions in the risk of developing vision-threatening complications. The rates of serious ocular adverse events and intraocular inflammation in treated patients treated were similar across both studies.

Diabetic retinopathy is the leading cause of blindness among working-age American adults, affecting more than 8 million people in the United States alone.

Regeneron is seeking an additional dosing regimen with a longer-term interval between doses. The PDUFA date is Feb. 28, 2023.



FDA Accepts sBLA for Eylea in Diabetic Retinopathy

 a complete response letter (CRL) for Spero Therapeutics’ new drug application (NDA) seeking approval for tebipenem HBr oral tablets. Spero was seeking an indication as a treatment of adult patients with complicated urinary tract infection (cUTI), including pyelonephritis, which is a UTI that has traveled to one of the kidneys.

In the CRL, the FDA indicated that Spero’s phase 3 study, ADAPT-PO, was insufficient to support approval and that an additional clinical study would be required. Spero officials said they intend to request a Type A meeting with the FDA to gain further insights as to the pathway forward for regulatory approval.

“We are disappointed with the FDA’s decision, but we look forward to our continued dialogue, addressing the agency’s concerns and outlining a clear path forward for tebipenem HBr,” Ankit Mahadevia, M.D., chief executive officer of Spero Therapeutics, said in a press release.

The CRL was anticipated based on feedback the company had received from the FDA in May 2022, in which the agency said there were potential deficiencies in the application.

 in May that, as a result of the FDA’s feedback, it was reducing its workforce by about 75% and a restructuring of its operations to reduce operating costs and reallocate resources toward the clinical development programs of SPR720 and SPR206, while continuing engagement with the FDA on the appropriate path forward for tebipenem HBr.

SPR720 is a novel oral therapy candidate for the treatment of a rare, orphan pulmonary disease caused by non-tuberculous mycobacterial infections. A phase 2 trial for this indication is expected to begin in the second half of 2022.

SPR206 is aimed at treating MDR gram-negative bacterial infections. Company officials said SPR206’s phase 1 data support further development in complicated urinary tract infection, hospital-acquired and ventilator-associated bacterial pneumonia, and bloodstream infections. A phase 2, cross-indication resistant pathogen study is expected to begin in the second quarter of 2023.

Spero Therapeutics was seeking approval for tebipenem HBr oral tablets for treatment of adult patients with complicated urinary tract infection. The FDA has requested an additional clinical trial.

FDA Issues Complete Response Letter for UTI Therapy

 its updated Performance Drug List, Standard Control formulary list. Effective July 1, the company has removed seven products from this formulary, according to a review conducted 

 comparing the April 2022 and the July 2022 Standard Control Formulary lists. 

(See table below for a list of the products added and removed.)

A CVS Caremark spokesperson indicated that an additional eight drugs have been removed but wouldn’t disclose the names of those products.

“Our template formularies remain critical tools in helping clients save money as they recover from the economic impacts of COVID-19, while continuing to provide affordable prescription drug benefits to their members,” the spokesperson told 

. “It’s important to note that the vast majority of our 100 million CVS Caremark members will be able to stay on their current therapy.

“Since CVS Caremark was the first PBM to implement formulary exclusions in 2012, we have used formulary management to negotiate better pricing and greater discounts to reduce costs for payers when clinically equivalent alternatives are available. We remain focused on ensuring that members get access to clinically appropriate medicines at the lowest possible cost.”

CVS Caremark has also added 14 products, including Eliquis (apixaban), which had been 

 from the drug list for this year. The CVS Caremark spokesperson said they was able to secure a lower net cost through negotiations with the manufacturer. But this change doesn’t not appear on the list just published on CVS Caremark’s website. The spokesperson said the change will be reflected the next time the formulary documents are updated, which is currently scheduled in advance of October 1, 2022.

Eliquis, developed by Bristol Myers Squibb, is an anticoagulant approved to treat and prevent blood clots and stroke. The decision to put Eliquis back on the formulary comes after objections from patients and patient groups. The American College of Cardiology and the American Society of Hematology have been involved in pushing back on CVS Caremark’s formulary decision.

The alternatives CVS Caremark had recommended for Eliquis included warfarin or Xarelto (rivaroxaban). This exclusion sparked concern among doctors and patients about “non-medical switching.” Patient and patient advocate Beth Waldron had been outspoken about the negative impact this exclusion could have on patients.

Waldron had been notified by mail in November 2021 that Eliquis, a therapy she had been taking eight years and was stable on, would no longer be covered. “For me personally, for my type of blood clots, the clinical studies show that patients have lower risk of recurrent clot and lower risk of major bleeding—including intracranial and serious internal bleeding abdomen while taking Eliquis,” she said in a recent interview.

 showed that patients with venous thromboembolism (VTE) who started on Eliquis had lower rates for recurrent VTE and bleeding than those who started on Xarelto.

One product removed is Novartis’ Afinitor Disperz (everolimus tablets for oral suspension), an anticancer agent approved to treat patients with breast cancer, neuroendocrine tumors of the lung and gastrointestinal, kidney tumors, and renal cell carcinoma. Several generics have been approved and are available. The first generic was launched in December 2019 when Par offered three strengths: 2.5 mg, 5 mg, and 7.5 mg.

More recently, Biocon launched a generic everolimus in October 2021. It was approved in February 2021. Biocon launched four strengths: 2.5 mg, 5 mg, 7.5 mg and 10 mg. Additionally, Breckinridge Pharmaceutical launched a 10 mg strength of generic everolimus in October 2021. The company had launched the three other strengths in the second quarter of 2021.

Afinitor Disperz tablet for oral suspension is also approved for the treatment of tuberous sclerosis complex (TSC)-associated subependymal giant cell astrocytoma and TSC-associated partial-onset seizures. On October 1, 2021, Mylan/Viatris launched the first generic version for this indication.

Also removed is Novo Nordisk’s GlucaGen Hypokit (glucagon) and Freenius Kabi’s Glucagon emergency kit, which are used to treat low blood sugar in patients with diabetes. CVS Caremark’s recommended alternatives include recommends Lilly’s Baqsimi (glucagon nasal powder), Xeris Pharmaceuticals’ Gvoke, (glucagon injectin) and Zealand Pharma’s Zegalogue (dasiglucagon injection), which has been added to the Standard Control Formulary beginning in July. The FDA approved Zegalogue in March 2021.

Other products removed include Movantik (naloxegol) to treat constipation that is caused by opioids, from RedHill Biopharma, Pentasa (mesalamine) to treat and prevent flare-ups of ulcerative colitis from Takeda Pharmaceuticals, and Dexilant (dexlansoprazole) to treat erosive esophagitis and heartburn associated with symptomatic non-erosive gastroesophageal reflux disease from Takeda Pharmaceuticals.


Effective July 1, 2022, CVS Caremark has removed seven drugs and added 14 to its Standard Control Formulary.


New FDA Proposal Would Make Adding OTC Approval to Prescription Drugs Easier

Sanofi Lowers Insulin Price

FDA Accepts sBLA for Eylea in Diabetic Retinopathy

FDA Issues Complete Response Letter for UTI Therapy

CVS Caremark Drops Several Products from Drug List