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

 Rebyota, the first fecal microbiota product for the prevention of recurrence of 

 infection (CDI) in people 18 years of age and older.

The human microbiome is a complex community of microorganisms in and on the body. In the gut, if a microbial imbalance occurs, this can lead to 

, irritable bowel syndrome or even diabetes. 

 is a serious disease that causes severe diarrhea, fever, stomach tenderness or pain, loss of appetite, nausea, and colitis. It has been estimated that up to 35% of cases recur after initial diagnosis.

Rebyota (formerly RBX2660) is a fecal microbiota transplantation therapy that was developed by Rebiotix, a Ferring Pharmaceuticals company. It is administered rectally as a single dose and is prepared from stool donated by qualified individuals. The donors and the donated stool are tested for a panel of transmissible pathogens.

“Until now, patients living with the devastating cycle of recurrent 

 infection have had limited FDA-approved treatment options, causing them to suffer long periods of time with debilitating symptoms that prevent them from leaving their homes and even separate them from immediate family members,” Paul Feuerstadt, M.D., Yale University School of Medicine, said in a 

The approval is based on the results from the clinical program including the phase 3 PUNCH CD3 trial in which a single dose of Rebyota demonstrated superiority to placebo as a treatment to reduce recurrence of 

 infection after standard-of-care antibiotic treatment. In the trial, 262 people received either Rebyota or placebo, and the primary endpoint was absence of CDI diarrhea within eight weeks after completing study treatment. The success rate at eight weeks for Rebyota was 70.6% versus 57.5% for placebo. More than 90% of study participants who achieved treatment success remained free of 

 infection recurrence through six months.

In the study, adverse events were primarily mild-to-moderate and there were no treatment-related serious adverse events. Incidence of treatment-emergent adverse events was higher in Rebyota recipients compared with placebo, mostly driven by a higher incidence of mild gastrointestinal events.

FDA Advisory Committee Gives Positive Vote for Microbiota-based C. Diff Therapy

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) issued a 

 on Sept. 22, 2022, for Rebyota. The committee voted 13 to 4 indicating that the data were adequate to support the effectiveness of RBX2660 to reduce the recurrence of 

 infection in adults 18 years of age and older following antibiotic treatment. The committee also voted 12 to 4 with one abstention that the data were adequate to support the safety of RBX2660.

Articles

Rebyota is the first fecal microbiota product to prevent recurrence of C. diff infection, a serious and potentially life-threatening disease.

FDA Approves Rebyota, the First-ever Microbiota Product

Prior authorization is harming people with cancer, said doctors who responded to a recent 

 from the Association for Clinical Oncology (ASCO). Oncologists indicated that prior authorization delays necessary care, worsens cancer care outcomes, and diverts clinicians from caring for their patients.

Nearly all survey participants report a patient has experienced harm because of prior authorization processes, including significant impacts on patient health such as disease progression (80%) and loss of life (36%). The most widely cited harms to patients reported are delays in treatment (96%) and diagnostic imaging (94%); patients being forced onto a second-choice therapy (93%) or denied therapy (87%); and increased patient out-of-pocket costs (88%).

Other harms Include: disease progression, patient forced to alternate site of service, denial of genetic testing, hospitalization/emergency rooms visits, denial of supportive care, patient abandoned care, and denial of cancer screenings.

“The survey results confirm what ASCO members have been experiencing first-hand for years, which is that large numbers of patients face indefensible delays or denials of cancer care,” ASCO Board Chair Lori J. Pierce, M.D., said in a 

. “We now have a clearer picture of the extent to which those hurdles lead to poorer patient outcomes, including reports of deaths. It would be unconscionable for policymakers to leave current prior authorization requirements and their effects on people with cancer unexamined.”

ASCO surveyed members from June 27, 2022 through July 30, 2022, and received 300 responses. Most respondents identified medical oncology as their primary area of clinical practice (55%) and were comparably distributed across community/hospital-based health network/systems (35%), private practice (34%), and academic/university (29%) settings

• It takes a payer five business days to respond to a prior authorization request

• A prior authorization request is escalated beyond the staff member who initiates it 34% of the time

• Prior authorizations are perceived as leading to a serious adverse event for a patient with cancer 14% of the time

• Prior authorizations are “significantly” delayed (by more than one business day) 42% of the time.

Additionally, nearly all respondents report experiencing burdensome administrative requirements, delayed payer responses, and a lack of clinical validity in the process.

, ASCO officials said another burden is “peer-to-peer” communication, which is often a call between the doctor and the payer. In many cases, ASCO finds the payer representative is not an oncologist.

ASCO is recommending that payers be accountable for prior authorization efficiency and impact and suggests that the Centers for Medicaid & Medicaid Services require reporting on patient experience, timeliness of determinations, and extent of prior authorization use. In addition, ASCO suggests the practice of piecemeal authorization — requiring prior authorization for individual medically necessary services performed during an invasive procedure that has already received prior authorization — should be prohibited.

ASCO is also suggesting that legislators require PBMs to incorporate accurate formulary data and prior authorization requirements into electronic health records. “The lack of transparency in the prior authorization process makes it difficult for providers and patients to evaluate the effectiveness, potential impact, and costs of prior authorization processes,” ASCO leaders wrote.

Doctors surveyed by the Association for Clinical Oncology said payer prior authorization can cause disease progression and loss of life.

Survey: Oncology Doctors Say Prior Authorization Hurts Patients

A broken vial has been found among additional lots of Exela Pharma Sciences’ sodium bicarbonate injection. As a result, the company is recalling 14 more lots. (Labels shown below.) This is in addition to the 49 lots recalled in October 2022, also because of broken vials. The additional lots were distributed October 26, 2021, through April 25, 2022.

Sodium bicarbonate injection is used for treatment of metabolic acidosis, which is the buildup of acid in the body because of kidney or liver failure.

Related: Vial Breakage Leads to Recall of 49 Lots of Sodium Bicarbonate

During the latest inspection of Exela’s retained product from the 14 lots, one vial showed breakage, which presents the potential for flying glass injuring skin and eyes. There have been no reports of breakage or injury from the additional lots, but previously Exela received five reports of flying glass and injury among the lots involved in the first recall.

The total 63 recalled lots include more than 2.7 million vials. There have been no reports of sterility failures to date with any of the 63 lots.

The product is packaged in a 50 mL glass vial, 20 vials per carton. The recall includes both the Exela brand (Carton NDC: 51754-5001-5; Vial NDC: 51754-5001-1) and Civica brand (Carton NDC: 72572-740-20; Vial NDC: 72572-740-1). Lot numbers and expiration dates can be found 

Exela Pharma is recalling an additional 14 lots of sodium bicarbonate injection because of a broken vial.

Exela Pharma Expands Recall of Sodium Bicarbonate

 for priority review Regeneron Pharmaceuticals’ supplemental biologics license application (sBLA) for Evkeeza (evinacumab-dgnb) to treat children aged 5 to 11 years with homozygous familial hypercholesterolemia (HoFH). The FDA target action date is March 30, 2023.

Homozygous familial hypercholesterolemia is an ultra-rare inherited condition that affects about 1,300 patients in the United States and is the most severe form of familial hypercholesterolemia. The disease occurs when two copies of the familial hypercholesterolemia-causing genes are inherited resulting in dangerously high levels of low-density lipoprotein-cholesterol (LDL-C). People with this condition are at risk for premature atherosclerotic disease and cardiac events even in their teenage years.

Evkeeza is a fully human monoclonal antibody that binds to and blocks the function of ANGPTL3, a protein that inhibits lipoprotein lipase and endothelial lipase and regulates circulating lipids, including LDL-C. It was first approved by the FDA in February 2021 for patients 12 years of age and older.

The application is supported by data from a three-part trial evaluating Evkeeza in children aged 5 to 11 years with homozygous familial hypercholesterolemia. Data from the Part B portion of the 

 were released in May 2022. Despite treatment with other lipid-lowering therapies, the 14 enrolled children entered the trial with low-density lipoprotein-cholesterol levels that are more than twice the target for pediatric patients with HoFH.

The trial met its primary endpoint, showing children who added Evkeeza to other lipid-lowering therapies reduced their LDL-C by 48% at week 24 on average. Additionally, 79% saw their LDL-C reduced by at least half at 24 weeks following Evkeeza treatment. The safety profile of Evkeeza was generally consistent to those seen in adults and pediatric patients aged 12 years and older. Most reported adverse events were mild or moderate, and none led to study discontinuation.

“Children living with HoFH have an incredibly rare and severe disease that causes dangerously high LDL-C levels. On current treatment options alone, many patients don't reach their treatment goals, leaving them with an uncertain future,” investigator M. Doortje Reijman, M.D., research associate in Pediatric Metabolic Diseases and Nephrology at the Amsterdam University Medical Center said in a press release.

If approved, Evkeeza would be the first treatment to help children as young as 5 years old control high LDL cholesterol caused by homozygous familial hypercholesterolemia. The FDA target action date is March 30, 2023.

FDA Accepts sBLA for Evkeeza for Children with Rare High Cholesterol 

Genentech, a member of the Roche Group, is voluntarily 

 the U.S. accelerated approval of Tecentriq (atezolizumab) for the treatment of adults with locally advanced or metastatic urothelial carcinoma (bladder cancer). The FDA had granted accelerated approval for Tecentriq in 2018 for patients who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.

Genentech made this decision to withdraw this indication following consultation with the FDA after the phase 3 IMvigor130 trial did not meet the co-primary endpoint of overall survival (OS) for Tecentriq plus chemotherapy compared with chemotherapy alone. These data will be presented at an upcoming medical meeting. IMvigor130 was the designed to be the postmarketing trial to convert the accelerated approval to regular approval.

An estimated 81,000 cases of bladder cancer will be diagnosed in the United States in 2022. Urothelial carcinoma, which develops in the cells of the bladder lining, is the most common type of bladder cancer, accounting for about 90% of all cases. In total, 30% of cases are considered advanced based on muscle-invasive or metastatic disease.

“There is a considerable unmet need for effective and tolerable treatments for people living with advanced bladder cancer and so we regret that the IMvigor130 trial did not cross the statistical threshold for overall survival,” Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development, said in a press release.

Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. It is currently approved to treat both small- and non-small cell lung cancer, hepatocellular carcinoma, and melanoma.

Genentech Withdraws Tecentriq Approval for Metastatic Breast Cancer

Last year, Genentech withdrew the accelerated approval for Tecentriq in combination with chemotherapy (Celgene’s Abraxane, albumin-bound paclitaxel) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1.

A confirmatory trial of Tecentriq in urothelial carcinoma failed to meet the co-primary endpoint of overall survival.


Genentech Withdraws Tecentriq Indication for Bladder Cancer

 a complete response letter (CRL) for the Y-mAbs Therapeutics’ biologics license application (BLA) for the investigational medicine omburtamab to treat patients with CNS/leptomeningeal metastasis from neuroblastoma. This follows the outcome of October 2022 advisory committee 

 against omburtamab. The FDA’s Oncologic Drug Advisory Committee (ODAC) voted 16 to 0 that the company had not provided sufficient evidence to conclude that omburtamab improves overall survival.

Neuroblastoma is the most common solid tumor in childhood with about 650 cases diagnosed in the United States per year. Central nervous system/leptomeningeal metastases are a rare and difficult-to-treat late-stage complication in which cancer cells from other affected areas spread to the meninges in the brain.

Omburtamab is a monoclonal antibody radiolabeled with Iodine-131 that targets B7-H3, an immune checkpoint molecule that is widely expressed in tumor cells of several cancer types. The omburtamab BLA is for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma.

The submission was based on the safety and efficacy results of the pivotal phase 2 studies 101 and 03-133. According to the company, 

 for 32 patients enrolled showed a 12-month overall survival (OS) of 73.5%, with a median follow-up of 25 months, and an objective response rate (ORR) of 31.3% in the patients with measurable disease after central review based on Response Assessment in Neuro-Oncology (RANO) criteria and European Association of Neuro-Oncology (EANO)/European Society for Medical Oncology (ESMO) criteria, and that a total of 75.0% of the patient with measurable disease achieved disease control. Serious adverse events found in 40.6% of the patients and were mostly related to myelosuppression.

Regulators’ concern centered around whether the studies demonstrated a treatment effect. Specifically, they said, the Study 03-133 was a single-arm trial. “OS should generally be evaluated in randomized trials because data from externally controlled trials may not be reliable or interpretable,” regulators wrote in a 

. “Apparent differences in outcome between external controls and current treatment groups can arise from factors other than the drug under investigation, such as differences in patient or disease characteristics, supportive care, concomitant treatments, or other factors.”

The FDA performed additional analyses to examine bias and these results indicated that differences in survival cannot be reliably attributed to omburtamab. Regulators indicated that the application did not include reliable response rate data to provide supportive evidence of the treatment effect of omburtamab.

“This is a tough situation. I think we are all motivated to provide more therapeutics to these patients who desperately need them. The issue here is whether there is clear overall survival and this bar has not been met,” committee member Christopher H. Lieu, M.D., said after the vote. He is associate director for Clinical Research and co-director of Gastrointestinal Medical Oncology University of Colorado Cancer Center.


In October, an FDA advisory committee voted against omburtamab, saying the trials didn’t show evidence that the therapy improves overall survival.


FDA Issues CRL for Therapy for Brain Metastasis from Neuroblastoma 

 for priority review Innoviva’s new drug application (NDA) for SUL-DUR to treat patients with infections caused by 

 complex (ABC). The agency is planning to hold an advisory committee meeting to discuss this application. The target PDUFA date is May 29, 2023.

 complex results in severe pneumonia and bloodstream infections, as well as infections of the urinary tract and the skin. ABC is considered a global threat in the healthcare setting due in part to its ability to acquire multidrug resistance.

 infections are among the top antibiotic-resistant threats, according to the Centers for Disease Control and Prevention. Those at risk include hospital-based patients who are on ventilators, have devices such as catheters, have open wounds and are in intensive care units. An estimated 8,500 infections in hospitalized patients and 700 estimated deaths in the United States are caused by carbapenem-resistant 

Sulbactam-durlobactam (SUL-DUR) is an intravenous drug that is a combination of sulbactam, an IV β-lactam antibiotic, and durlobactam, a broad-spectrum IV β-lactamase inhibitor, being developed to treat infections caused by ABC, including multi-drug and carbapenem-resistant strains.

“Carbapenem-resistant and multidrug-resistant 

 infections are an urgent and emergent threat due to increasing rates of resistance and few viable treatment options,” David Altarac, M.D., chief medical officer of Entasis Therapeutics, a subsidiary of Innoviva, said in a press release. SUL-DUR was developed by Entasis, which was acquired by Innoviva in July 2022.

The application is based on the phase 3 ATTACK trial. In the trial, SUL-DUR demonstrated statistical non-inferiority versus colistin, a last-resort antibiotic for drug resistant pathogens, for the primary endpoint of 28-day all-cause mortality in patients with carbapenem-resistant ABC infections and a significant difference in clinical cure rates. In part A of the study, clinical cure rates were 61.9% for SUL-DUR and 40.3% versus colistin.

SUL-DUR also exhibited a favorable safety profile with statistically significant reduction in nephrotoxicity, 13.2% for SUR-DUR versus 37.6% for colistin.

SUL-DUR is a targeted antibiotic designed to treat serious drug-resistant infections. The target PDUFA date is May 29, 2023, and the FDA plans to hold an advisory committee meeting to discuss this application.

FDA Accepts Application for Antibiotic for Drug-Resistant Infections

 a second indication Brexafemme (ibrexafungerp) to reduce the incidence of recurrent vulvovaginal candidiasis (VVC). Developed by Scynexis, Brexafemme is an oral triterpenoid antifungal that FDA approved to treat vulvovaginal candidiasis in June 2021. The therapy represents a new antifungal class in more 20 years and is the only treatment for vaginal yeast infections that is both oral and non-azole. It has broad activity on a range of 

 species, including azole-resistant strains.

Current treatments, including the oral Diflucan (fluconazole), for vaginal yeast infection are azole antifungals. About 7% of all 

 at the Centers for Disease Control and Prevention are resistant to fluconazole. Resistance is most common with 

“Brexafemme, which has the ability to kill the infection-causing fungi, also can reduce the incidence of VVC episodes, benefiting many patients who have repeated infections and inadequate treatment options,” David Angulo, M.D., chief medical officer of Scynexis, said in a press release.

The approval is based on positive results from the pivotal phase 3 CANDLE study that evaluated the safety and efficacy of monthly dosing of Brexafemme to reduce the incidence of recurrent vulvovaginal candidiasis. Results showed that 65.4% of patients receiving the treatment achieved clinical success by having no recurrence at all through week 24 compared with 53.1% of placebo-treated patients. The advantage of Brexafemme over placebo was sustained over the three-month follow-up period and remained statistically significant. In the study, Brexafemme was generally safe and well-tolerated. The most commonly reported adverse events were headaches or were gastrointestinal in nature (i.e., diarrhea, nausea), and were mostly mild and generally consistent with the previous Brexafemme label.

The average retail price is $596.26 for four tablets, according to 

. Brexafemme received coverage from a major national PBM representing 21 million commercially covered lives in October 2022, according a company presentation.

Brexafemme is a non-azole oral antifungal now approved to both treat and prevent recurrent yeast infections in women.

FDA Approves Second Indication for Brexafemme

 Citius Pharmaceuticals’ biologics license application (BLA) for I/Ontak (denileukin diftitox) to treat patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL). The Prescription Drug User Fee Act (PDUFA) target action date is Sept. 28, 2023.

Cutaneous T-cell lymphoma is a type of cutaneous non-Hodgkin lymphoma (NHL) that comes in a variety of forms and is the most common type of cutaneous lymphoma. In CTCL, T-cells, a type of lymphocyte that plays a role in the immune system, become cancerous and develop into skin lesions.

I/Ontak is an engineered IL-2-diphtheria toxin fusion protein. I/Ontak specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. It is a purified and more bioactive formulation than the previously FDA-approved Ontak.

Ontak was marketed in the United States from 1999 to 2014, when it was voluntarily withdrawn from the market because of production issues related to the 

 expression system and purification challenges. Company officials said manufacturing improvements resulted in a new formulation that maintains the same amino acid sequence but features improved purity and bioactivity.

The BLA is supported by a pivotal phase 3 study. Topline 

 released in April 2022 showed that I/Ontak demonstrated anti-tumor activity in the treatment of persistent or recurrent CTCL. I/Ontak provided disease control without cumulative toxicity and has an average time to response within one to two cycles of treatment in patients that have failed multiple prior therapies. The primary outcome measure was objective response rate (ORR), defined as the proportion of subjects with a significant reduction in tumor size that can be classified as achieving either a partial response or a complete response.

An independent review committee determined the study achieved an objective response rate of 36.2% and an investigator efficacy analysis determined that the study achieved an objective response rate of 42.3%. Overall rates of adverse events and serious adverse events were consistent with published data of previously approved Ontak. Most common adverse events included: nausea, fatigue, increased alanine aminotransferase, chills and peripheral oedema. No new safety concerns were identified.

“I/Ontak has a unique dual mechanism of action that exerts both direct tumor cell killing and transient elimination of immunosuppressive Tregs within the tumor microenvironment. If approved, we believe this biologic with its observed efficacy and safety data would arm oncologists in the United State with an important additional treatment option for this devastating orphan disease,” Myron Czuczman, M.D., chief medical officer of Citius, said in a press release in April.

 it is beginning research to evaluate I/Ontak in combination with Keytruda (pembrolizumab) to treat patients with recurrent or metastatic solid tumors. The University of Pittsburgh will be conducting a dose-ranging study. Additionally, Citius is collaborating with the University of Minnesota for a dose-finding study to evaluate I/Ontak before (Kymriah) tisagenleucel CAR-T therapy in patients with diffuse large B-cell lymphoma. The trial enrolled its first patient in May 2021.

I/Ontak is an engineered IL-2-diphtheria toxin fusion protein. The PDUFA target action date is Sept. 28, 2023.

FDA Accepts BLA for Cutaneous T-Cell Lymphoma Therapy

The latest trial results show Biogen and Eisai’s investigational Alzheimer’s disease drug lecanemab slowed cognitive in early disease, but safety questions remain. While two deaths have been reported during clinical trials, the manufacturers do not believe the deaths were caused by the medication.

Deaths occurred in 0.7% of patients in the lecanemab and 0.8% of patients in the placebo group, and no deaths were related to lecanemab in the 18-month double-blind study period, Michael Irizarry, M.D., senior vice president of clinical research and deputy chief clinical officer of Alzheimer’s Disease and Brain Health at Eisai, told 

 that a 65-year-old woman with early Alzheimer’s disease in the clinical trial died from a massive brain hemorrhage that some researchers link to the drug. The clinical trial death, which described in an unpublished case report 

 obtained, is the second thought to be associated with lecanemab, according to the publication.

“The two cases on lecanemab occurred in the open-label extension study. Both cases had significant comorbidities and risk factors including anticoagulation contributing to macrohemorrhage or death. Therefore, it is Eisai’s assessment that the deaths cannot be attributed to lecanemab,” the pharma maker said in a statement to 

Lecanemab is an investigational anti-amyloid beta antibody being developed jointly by Eisai and Biogen for the treatment of mild cognitive impairment due to Alzheimer’s disease. It is currently under review by the FDA and a decision is expected by Jan. 6.

Biogen and Eisai released new clinical trial results at the 2022 

Clinical Trials on Alzheimer’s Disease (CTAD) conference

 held in San Francisco and virtually November 29-December 2. In the core study and subsequent open-label extension study, rates of deaths with concurrent cerebral macrohemorrhage were 0.1% in both the placebo group (1/897) and the lecanemab group (2/1,608), Eisai said.

In the phase 2 Clarity AD study, the rate of macrohemorrhage in the subjects on both anticoagulants and lecanemab was 2.4% and 3.6% across the core phase and the open-label extension phases, Irizarry said. “Background rate of macrohemorrhage in AD patients on anticoagulation is not known,but is expected to be higher than in non-AD patients due to cerebral amyloid angiopathy (CAA); therefore, comparative risk is difficult to assess.”

Irizarry also noted that “the well-being of the patients enrolled in our clinical studies is always Eisai’s top priority. Eisai has established a rigorous safety monitoring process to ensure patient safety. This includes an independent data safety monitoring committee of external experts.”

The independent Data Safety Monitoring Board (DSMB) review of all ARIA-related safety data from the clinical study found that “all the available safety information indicates that lecanemab therapy is not associated with an increased risk of death overall or from any specific cause,” Irizarry noted.

Serious adverse events were experienced by 14% of participants in the lecanemab group and 11.3% of participants in the placebo group. Treatment-emergent adverse events occurred in 88.9% and 81.9% of participants in the lecanemab and placebo groups, respectively, Eisai and Biogen said in a 

. Treatment-emergent adverse events leading to drug withdrawal occurred in 6.9% and 2.9% of participants in the lecanemab and placebo groups, respectively.

The most common adverse events in the lecanemab group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall. Infusion reactions were largely mild-to-moderate and occurred on the first dose.

Despite adverse events, the Clarity AD study showed that lecanemab treatment resulted in “highly statistically significant results,” reducing clinical decline on the global cognitive and functional scale, compared with placebo at 18 months — a 27% slowing of decline, Eisai and Biogen said.

All key secondary endpoints also showed highly statistically significant results compared with placebo. In the amyloid PET sub-study, treatment with lecanemab showed statistically significant reduction in amyloid plaque burden at all timepoints starting at 3 months.

“We believe that the results of Clarity AD are an important step forward in the field of Alzheimer's disease…The insights from the Clarity AD data will deepen our understanding of the disease to pursue further advancement of the treatment of the disease,” Irizarry said.

Lecanemab is an investigational anti-amyloid beta antibody to treat mild cognitive impairment due to Alzheimer’s disease. It is currently under review by the FDA and a decision is expected by Jan. 6. 

FDA Issues CRL for Therapy for Brain Metastasis from Neuroblastoma

FDA Accepts Application for Antibiotic for Drug-Resistant Infections

FDA Approves Second Indication for Brexafemme

FDA Accepts BLA for Cutaneous T-Cell Lymphoma Therapy

Safety Questions Follow Positive Results for Lecanemab in Alzheimer’s