This Week at FDA: Leqembi fully approved, Senators at odds over PAHPA, and more

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, FDA gave full approval to an Alzheimer's drug that may have huge consequences for Medicare, top Senators are squaring off over key pandemic legislation, and an important report upheld that FDA doesn't need Congressional oversight when implementing risk evaluation and mitigation strategies (REMS).

Leading the news this week, FDA has converted Eisai and Biogen’s Alzheimer’s drug Leqembi (lecanemab-irmb) from accelerated approval to a traditional approval after a confirmatory trial verified the drug’s clinical benefit. Leqembi initially received accelerated approval in January and is the first amyloid beta-directed antibody to get traditional approval to treat Alzheimer's.

Leqembi works by reducing amyloid plaque in the brain and its full approval is expected to mean broader coverage of the $26,500-a-year drug from the Center for Medicare and Medicaid Services’ (CMS) Medicare program for people 65 and older.

The Government Accountability Office (GAO) released a report this week that found that the Congressional Review Act (CRA) does not come into play when FDA makes changes to a Risk Evaluation and Mitigation Strategies (REMS) program under its regulations. As AgencyIQ notes, if the rule had come under CRA oversight, it would have effectively neutered the agency's "ability to regulate certain controversial products independently."

Politico and Endpoints reported this week that the two top senators on the Senate Health, Education, Labor and Pensions (HELP) Committee are at odds over reauthorizing the Pandemic and All-Hazards Act (PAHPA). While HELP Chair Bernie Sanders (I-VT) reportedly wants to cap costs for products supported by the Biomedical Advanced Research and Development Authority (BARDA) or the Centers for Disease Control and Prevention (CDC), Ranking Member Bill Cassidy (R-LA), wants a reauthorization and expansion of FDA’s medical countermeasures priority review voucher program.

On a separate issue, the HELP subcommittee on health is meeting next week to discuss the impact of antimicrobial resistance on modern medicine. Public health experts have long warned about the dangers of antimicrobial resistance, cautioning that without new antibiotics coming to market the current arsenal of drugs may be useless in preventing future outbreaks of antimicrobial resistance infections.

Drugs & biologics

FDA's Center for Biologics Evaluation and Research's (CBER) Office of Therapeutic Products (OTP) plans to host a virtual town hall on 30 August to answer stakeholder questions regarding nonclinical assessment of cell and gene therapy products. The agency notes that data from such studies provide information on the safety and activity profile of an investigational product and guide the design of early-phase clinical trials.

FDA has released its latest monthly data from the Generic Drug User Fee Amendment (GDUFA III) program. The agency says it has approved 495 generic drugs, tentatively approved another 123 products and has handed out 1,031 complete responses since October 2022.

FDA is convening its Medical Imaging Drugs Advisory Committee on 1 August to discuss dosimetry data needed to support the initial clinical study in an original investigational new drug (IND) application for certain new positron emission tomography (PET) drugs. Among the issues set for discussion, the agency wants the external experts thoughts on what is considered sufficient data from animal or human studies involving certain positron emitting radionuclides to reasonably calculate the amount of radiation that may be absorbed by people using PET drugs that contain the radionuclides.

Reuters reports that Amneal Pharmaceuticals has received a complete response letter (CRL) from FDA for its experimental Parkinson's drug IPX203, which is a combination of levodopa and carbidopa. The company says the agency was not convinced about the safety of the drug and has asked for additional data. The company says it plans to work with the agency to address the issue.

Indian drug-maker Cipla is recalling six batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg, manufactured in November 2021 after it received a complaint for a leaking inhaler. The inhaler is used to treat and prevent bronchospasm with reversible obstructive airway disease and to prevent exercise induced bronchospasm. The recall notes that the defect could be life-threatening if patients do not receive the correct dose of the drug to treat their respiratory symptoms, though no adverse events have been reported so far.

FDA inspectors have handed Form 483s to two Indian drug manufacturers, Intas Pharmaceuticals and Ipca Laboratories, for allegedly failing to maintain current good manufacturing practices (CGMP) and for poor quality controls of their products.

FDA has sent a warning letter to South Korean drugmaker Lydia Co. Ltd. on 26 June for failing to provide complete, accurate and up-to-date establishment registration and drug listing information.

Medtech

Abbott announced this week FDA has given the thumbs up to its Aveir DR dual chamber leadless pacemaker, the first approval for such pacemakers. The devices are intended to treat people with abnormal or slow heart rhythms and provide synchronized or coordinated cardiac pacing between two leadless pacemakers based on the person's clinical needs.

Medtronic says it has identified a cybersecurity vulnerability that could potentially give hackers access to cardiac device data stored in its Paceart Optima data workflow systems, Fierce reports. According to a security bulletin posted by the company, the flaw is associated with the optional messaging feature that’s built into the Paceart Optima technology.

This Week at FDA: Leqembi fully approved, Senators at odds over PAHPA, and more

Related topics

Recommended content

Welcome to the new RAPS Digital Experience