FDA advisers back Alzheimer’s drug

✔ The FDA AdComm panel of outside advisers voted 6-0 that a large study confirmed the drug’s benefits for patients with mild or early Alzheimer’s. The nonbinding vote amounts to a recommendation for full approval, and the FDA is scheduled to issue a final decision on the matter by July 6.

#Alzheimers
#Biotechnology

The FDA is more likely to grant a broader approval to a closely watched therapy for Alzheimer’s disease, now that it’s gotten renewed backing from a committee of experts who advise the agency on brain medicines.

During a meeting Friday, the experts voted 6-0 that recently collected clinical trial data confirm the therapy, known as Leqembi, indeed benefits Alzheimer’s patients. The FDA is weighing whether to expand a conditional approval given to Leqembi earlier this year into a full one, and the committee’s conclusion may nudge the agency to do so.

An expanded approval could substantially increase how many patients can get ahold of Leqembi and other, similar Alzheimer’s drugs. Currently, the government insurance program Medicare, which covers the majority of people eligible to receive these drugs, has a policy in place that strictly limits access. But the program has signaled it will relax its rules for reimbursement if Leqembi secures full approval.

Wall Street analysts believe Leqembi, with greater insurance coverage, will become a blockbuster product for its developers Eisai US and Biogen. The team at the investment firm RBC Capital Markets, for instance, estimates the drug will eventually generate as high as $10 billion in annual sales.

The main trial supporting full approval found that participants declined 27% more slowly when given Leqembi compared to a placebo. The trial also used multiple, well-known tests for Alzheimer’s patients, and found positive data backing the drug’s effectiveness.

Since those results became available, Alzheimer’s doctors have debated the impact a treatment like Leqembi could have for patients. Some see the drug as an important victory in a research field marred by failure, while others believe it offers marginal benefits at best.

#alzheimers #drugdevelopment #research #biotechnology #FDA #neuroscience