Madrid, Spain-based Salvat has submitted a new drug application (NDA) for a new treatment for fungal otitis externa, clotrimazole, to the FDA. The pharmaceutical manufacturer expects the drug, if approved, to be available in the United States by the summer of 2023. Company officials 

 would be the first topical drug indicated to treat otomycosis, an ear infection caused by a fungus. It usually affects the outer ear canal.

“While there are other medications or formulations on the market that can help manage the symptoms of this condition, Salvat’s….is the only one focused on effectively treating otomycosis,” the company said.

Salvta enters a potentially lucrative market as the value of fungal otitis external medications was estimated at $169 million in 2021, according to 

. The group of medications is expected to produce a compounded annual growth rate of 2.9% from 2021 through 2028.

“This project is a reflection of the firm commitment we have made to R&D in the area of otology, and reinforces our leadership position in this therapeutic area, without losing focus on other areas of strategic growth for Salvat,” said Alberto Bueno, CEO of Salvat.

Salvat formulated clotrimazole for otic use in the form of single-dose vials, making it easier for patients to use, according to the company. “This format also ensures the sterility of the product and, by containing the necessary amount of active ingredient, also warrants the correct use of the drug,” Salvat said.

The NDA is based on two clinical trials conducted over three years in more than 400 adult patients affected by otomycosis. “Both studies have concluded with very positive results that confirm the efficacy and safety of the new drug for the eradication of the fungus that causes otomycosis and the associated clinical symptoms (pain, itching, feeling of fullness and hearing loss),” Salvat said.

Since 2019, Salvat has invested more than 22 million euros ($23 million) to develop this formulation of clotrimazole. Salvat also manufactures Otovel (ciprofloxacin and fluocinolone acetonide), a combination antibiotic and steroid medication for ear infections, and Cetraxal (ciprofloxacin) to treat acute otitis externa caused by ciprofloxacin susceptible microorganisms.

Articles

If approved, clotrimazole would be the first topical drug indicated to treat otomycosis, an ear infection caused by a fungus.

Salvat Submits NDA for Ear Infection Drug

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

 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

Prime Therapeutics, the Minnesota-based pharmacy benefit manager (PBM), announced today that it had finalized its acquisition of Magellan Rx Management from Centene.

 in May that it was buying the pharmacy division of Magellan for $1.35 billion and today’s announcement also used that figure.

Related: Prime Therapeutics to Acquire Magellan Rx

Centene, a dominant company in Medicaid managed care, acquired Magellan Health in January for $2.2 billion but has been selling off chunks of the parent company since. In addition to selling Magellan Rx to Prime Therapeutics, St. Louis-based Centene announced in November that it was selling Magellan Specialty Health to Evolent Health and would receive a total of $750 million the from the deal.

, Prime described the Magellan Rx as a specialty drug management business and a full-service PBM with 1.7 million members. Magellan Rx also has a large Medicaid pharmacy business

Centene’s press release in November announcing the deal with Evolent described Magellan Specialty Health as a “specialty benefit management organization that offers industry-leading utilization management solution.”

The PBM industry has become increasingly consolidated with about three-quarters of the business controlled by Express Scripts, Optum Rx and CVS Caremark. In 2019, Prime entered into three-year “collaboration” with Express Scripts.

When it announced the Magellan Rx acquisition in May, Prime said Magellan Rx would operate as a stand-alone business for the foreseeable future. Today’s announcement reiterated that asserition and mentioned that Mostafa Kamal will continue as Magellan Rx CEO and be part of Prime's executive leadership team. According to Kamal’s LinkedIn profile he has been CEO of Magellan Rx for seven years.

Magellan Rx's businesses includes a 1.7-million member PBM. The deal is struck amid a long-time trend toward consolidation in the pharmacy benefit management industry.

 Prime Therapeutics Completes $1.35B Deal to Acquire Magellan Rx

In 2021, seven out of 10 high-cost drugs had price increases that were not supported by clinical evidence, according to a new 

, Unsupported Price Increase Report, by the Institute for Clinical and Economic Review (ICER). These increases accounted for $805 million in additional costs over one year.

Top among these are: Salix Pharmaceuticals’ Xifaxan (rifaximin) to reduce the risk of overt hepatic encephalopathy recurrence in adults and to treat adults with irritable bowel syndrome with diarrhea; Janssen’s Invega Sustenna (paliperidone) to treat adults with schizophrenia and schizoaffective disorder; and Amgen’s Prolia (denosumab) to treat osteoporosis in both men and women. (See Table below for a list of the products in ICER’s report.)

“The norm in the United States has been for most pharmaceutical manufacturers to increase prices year after year — even accounting for the discounts they give insurers, and even for drugs that already sit at the top of the chart of spending for drugs in the United States,” David Rind, M.D., ICER’s chief medical officer, told 

. “The goal of ICER’s UPI report is to provide the public and policymakers an explicit and independent approach to determine whether price increases could potentially be supported by new clinical evidence. If new evidence emerges that shows a treatment may be more beneficial than what was previously understood, perhaps that new evidence could warrant some level of price increase. On the other hand, if there is no new evidence suggesting a treatment might be more beneficial for patients, then we can call that price increase unsupported.”

In this review, ICER obtained from SSR Health a list of the 250 drugs with the largest U.S. sales revenue in 2021. They excluded 101 drugs whose increase in wholesale acquisition cost (WAC) was not more than 2% greater than the increase in the medical consumer price index (CPI).

For the remaining products, ICER reviewers estimated the increase in spending that was due to net price versus volume. They asked manufacturers for input on changes in net price, sales volume, and overall net revenue and then generated a list of the top 10 drugs based on increase in spending due to increases in net price. To assess clinical evidence, the ICER reviewed manufacturers’ submissions and performed independent analysis of publicly available clinical trial results.

ICER also included three additional products that had the highest increases in total population-based spending by the Centers for Medicare and Medicaid Services (CMS) from 2019 to 2020 because of increases in unit prices. One of these products had been assessed previously by ICER. Of the three Medicare Part B drugs selected due to list price increases, all lacked supporting new evidence for their price increases. For these drugs, patients paying 20% coinsurance under Medicare Part B would have seen increases in individual out-of-pocket spending due just to the price increases ranging from $1,200 to $3,200 per year.

The three Medicare drugs assessed that did have important new clinical evidence were Cosentyx (Secukinumab), Tremfya (Guselkumab), and Jakafi (Ruxolitinib).

ICER reviewers in the report, however, stress they are not assessing whether the evidence supports the price increases. Rather, there are looking to see if new evidence exists that could justify a price increase.

“The point of the UPI report is to elucidate examples where manufacturers are taking price increases that are not supported by new evidence of benefits for patients,” Rind said. “When we find examples of drugs with new clinical evidence that might support a price increase, we remove those drugs from our list, so that policymakers and the public have a clear view of the drugs with price increases that are not supported by evidence.”

Source: Institute for Clinical and Economic Review

Seven of the 10 top selling drugs with high price increases lack the clinical evidence to justify those increases.

ICER: Drugs with Unsupported Price Increases Added $805 Million in Costs

Long before the approval of Biogen’s Aduhelm (aducanumab), long before people began to question whether clearing the brain of amyloid plaques slowed cognitive decline in Alzheimer’s disease, a small company in Aberdeen, Scotland, was quietly tackling a different research path.

TauRx Pharmaceuticals, founded in 2002, focused its research on the protein tangles in the brains of those with Alzheimer’s disease. The company’s founder, Claude Wischik, Ph.D., had previously identified tau as being at the core of the tangle filaments seen in patients with Alzheimer’s disease. His company worked to develop inhibitors of tau aggregation.

Two decades later, the phase 3 LUCIDITY trial has 

 that TauRx’s oral tau aggregation inhibitor, hydromethylthionine mesylate (HMTM), normalizes brain atrophy and stabilizes cognition. Data from this trial were recently presented at the Clinical Trials in Alzheimer’s Disease (CTAD) conference in San Francisco.

Tau has always been a hallmark of Alzheimer’s pathology, but a biomarker for beta amyloid plagues was found early on. That led to research primarily focused on clearing the brains of the amyloid plaques.

“Alzheimer’s disease is a complex disease,” Dr. Sonya Miller, head of medical affair at TauRx, told 

. “There is a greater understanding now about how beta amyloid and tau interact and of other signs of neuro degeneration, including neuroinflammation.”

TauRx has taken a slow and deliberate course for developing this novel compound. “What an earlier study showed us that we had some quite complex issues to deal with. One was the dose, and that had to do with an earlier formulation. We have a new formulation that has a designated stabilized salt form that delivers a reduced form of the drug,” Miller said.

Miller said they also took time to understand how HMTM works. They found that the compound led to a biological event at the synapses itself. An earlier study of HMTM that included pretreatment with acetylcholinesterase inhibitors found there was a down regulation that impacted the ability of the drug to work. This led company researchers to the current design of the trial with HMTM as a monotherapy.

In the study presented at CTAD, TauRx found that, in the 105 patients with mild cognitive impairment who received the 16 mg/day dose, there was statistically significant cognitive improvement over the pre-treatment baseline at six months, 12 months and 18 months on the Alzheimer’s Disease Assessment Scale-Cognitive (ADAS-cog). The mean change on the instrumental activities of daily living subscale of ADCS-ADL also remained above the pre-treatment baseline at six, 12 and 18 months.

In the 147 patients with mild-to-moderate Alzheimer’s disease there was a cognitive decline in the first nine months and no further decline over the following nine months. There was a functional decline in the activities of daily living.

Statistically significant reductions in disease progression as measured by change in cognitive function and brain atrophy were confirmed by comparisons of participants receiving the 16 mg/day dose against Alzheimer’s Neuroimaging Initiative (ADNI) subjects who were closest to the study population by age and clinical severity. Trial participants with mild cognitive impairment entered the study with more brain atrophy than ADNI healthy aging subjects and consistent with ADNI mild cognitive impairment subjects. 

Those treated with HMTM had a rate of progression of brain atrophy that was significantly less than in ADNI MCI subjects and comparable to that seen in ADNI healthy aging subjects. And, according to analysis comparing HMTM to publicly available data of amyloid-targeted treatments, the treatment effects of HMTM on cognitive and functional decline are about three-fold larger over 18 months.

There were no treatment-related serious adverse events or evidence of amyloid related imaging abnormalities. The trial experienced a 20% drop out rate, due to the logics of the COVID-19 pandemic, and people couldn’t travel to participate in the study, Miller said.

The open-label extension part of the LUCIDITY trial is ongoing, with planned completion in mid 2023.

The trial, however, had an unexpected outcome. The study had two treatment arms, HMTM and an active control, methylthionium chloride (MTC). HMTM and MTC share a parent compound, methylthionium. This control was chosen because both compounds discolor urine, and this was required to maintain blinding, Prof. Bjoern Schelter, data analytics and biostatistics lead of TauRx, said in an interview with 

But the active control resulted in accumulation of MT in plasma. “When we designed the trial, all the modeling suggested that there should be no activity from the control arm. We need some feedback and advice from regulators.”

The company plans to discuss the results first with the UK Medicines and Healthcare Products Regulatory Agency and then the FDA for guidance in the first and second quarter of 2023. TauRx has received an Innovative Licensing and Access Pathway (ILAP) for HMTM, which is a new fast track designation for innovative medicines approvals in the UK.

TauRx’s oral anti-tau therapy HMTM has shown in a phase 3 trial that it can stabilize cognitive decline in patients with Alzheimer’s disease. 

Anti-Tau Alzheimer’s Treatment Slows Cognitive Decline

Express Scripts and Cigna Pharmacy will add biosimilars as preferred products on its commercial formularies at the same position as AbbVie’s rheumatoid arthritis drug Humira (adalimumab) beginning in 2023.

“By placing biosimilars on our formularies in the same position as Humira, we’re also ensuring that physicians and patients have choice and flexibility as they assess these additional biosimilar therapies,” Katy Wong, chief pharmacy officer, Cigna Pharmacy, said in a 

A spokesperson indicated that the companies have not yet decide which of the seven Humira biosimilars will be available. In the coming months, Express Scripts and Cigna will continue to evaluate all biosimilar products to Humira for placement on its largest formularies and will provide updates related to specific changes as available.

Next year, seven biosimilars are expected to be launched, with Amgen’s Amjevita being the first in January. The others expected to launch in the second half of the year include: Merck’s Hadlima, Boehringer Ingelheim’s Cyltezo, Coherus BioSciences’ Yusimry, Viatris’ Hulio, Sandoz’ Hyrimoz, and Pfizer’s Abrilada.

Humira is a widely prescribed drug in the United States, with sales of more than $20 billion in 2021. Specialty drug costs, including Humira, represent 2% of prescriptions, yet account for 50% of drug cost spend with continued growth anticipated and are projected to reach $505 billion by 2023. Potential savings related to biosimilars could exceed $100 billion over the next five years.

Express Scripts has long advocated for the adoption of biosimilars. Last year, Express Scripts added Viatris’ Semglee (insulin glargine-yfgn), the first FDA-approved interchangeable biosimilar basal insulin, to its National Preferred Formulary beginning in 2022. The company estimates more than $20 million savings for plan sponsors in one year.

 the biosimilar business of Viatris, which includes the adalimumab and insulin glargine biosimilars, as well as other products in Viatris’ portfolio.)

Related: OptumRx to Cover Amgen’s Biosimilar of Humira

Express Scripts/Cigna Pharmacy is the second PBM to announce coverage of the Humira biosimilars. Recently, OptumRx announced plans to include on its formularies Amjevita and two additional biosimilars on the Select and Premium formularies.

Cigna and Express Scripts have not yet made a decision about which of the Humira biosimilars will be included but they will evaluate all products in the coming months.

Cigna, Express Scripts to Provide Humira Biosimilars as Preferred Products

 the resubmitted biologics license application for pegunigalsidase alfa to treat adult patients with Fabry disease. Fabry disease is a life-threatening, rare genetic disorder that can cause pain and impaired peripheral sensation and can lead to organ failure, particularly of the kidneys. It is caused by a deficiency of the lysosomal α–Galactosidase–A enzyme, which leads to abnormal deposits of a fatty substance called globotriaosylceramide (Gb3) in blood vessel walls. Fabry disease occurs in one person per 40,000 to 60,000.

Pegunigalsidase alfa (PRX–102) is an enzyme replacement therapy that was developed by Protalix BioTherapeutics and Chiesi Global Rare Diseases. It is a long-acting and chemically modified stabilized version of the recombinant α–Galactosidase–A enzyme. A Prescription Drug User Fee Act (PDUFA) action date is set for May 9, 2023.

The BLA resubmission includes a comprehensive set of clinical and manufacturing data. The data were compiled from studies that involved more than 140 Fabry disease patients with up to five years of follow up, including all three completed studies in the PRX-102 phase 3 clinical program including the BALANCE study, the BRIDGE study and the BRIGHT study, as well as the phase 1/2 clinical trial of PRX–102. The phase 1/2 data includes data compiled from the related extension study succeeding the phase 1/2 study. The BLA resubmission also includes safety data compiled from the ongoing phase 3 extension studies of PRX–102.

Related: Protalix, Chiesi Resubmit BLA to Treat Fabry Disease

The BLA has been resubmitted last month after receiving complete response letter from the FDA in April 2021. At the time, the agency indicated that travel restrictions limited the ability to complete inspections of Protalix’s manufacturing facility in Israel.

A Prescription Drug User Fee Act action date for pegunigalsidase alfa is set for May 9, 2023.

Prime Therapeutics Completes $1.35B Deal to Acquire Magellan Rx

ICER: Drugs with Unsupported Price Increases Added $805 Million in Costs

Anti-Tau Alzheimer’s Treatment Slows Cognitive Decline

Cigna, Express Scripts to Provide Humira Biosimilars as Preferred Products

FDA Accepts Resubmitted BLA for Fabry Disease