Regulatory FDA accelerated approval decision on Alzheimer’s drug likely to...

FDA accelerated approval decision on Alzheimer’s drug likely to come soon


According to Biogen and Eisai, the accelerated approval decision for their Alzheimer’s drug could be made in early January by the FDA.

Phase 3 trial results revealed that lecanemab appears to slow down the decline of cognitive ability and has shown potential as a treatment for Alzheimer’s. However, safety fears arose due to serious issues like bleeding and inflammation in the brain.

According to Eisai, the License Application for the accelerated approval and priority review of lecanemab was accepted by the FDA in July. Accelerated approval is for drugs that are for serious medical needs that are still unmet. Libby Holman, an Eisai spokesperson stated that January 6 is the expected date by which the FDA will make a decision. The Alzheimer’s Association (TAA) is also expecting an FDA decision by the same date.

Maria Carrillo, the CSO (chief science officer) of TAA stated, “We believe, based on the totality of positive data from clinical trials of this treatment, that the FDA should approve. Peer-reviewed, published results show lecanemab will provide patients in the earliest stages of Alzheimer’s more time to participate in daily life and live independently. It could mean many months more of recognizing their spouse, children, and grandchildren.”

She also said that the association has filed a request with CMS (Centers for Medicare and Medicaid Services) to make available complete unrestricted coverage for Alzheimer’s treatments that are approved by FDA. These therapies are not covered as of now. CMS decides whether or not to cover therapies approved by the FDA based on their effectiveness and safety.

The results of a 1.5-year phase 3 trial were published in November which showed that lecanemab slowed down the functional and cognitive decline in that period, but had adverse events. Just below 7% of the participants in the lecanemab group stopped the trial because of adverse events while only nearly 3% from the placebo group stopped the trial. A total of 14% of cases saw adverse events in the lecanemab group compared to 11.3% in the placebo group.

Reactions to the IV infusions and MRI abnormalities were the most prevalent adversities in the lecanemab group. Among these were life-threatening events like ARIA (amyloid-related imaging abnormalities). Few ARIA patients may not show symptoms but could lead to permanent damage in worst cases. The trial also revealed that six patients (0.7%) from the lecanemab group and seven patients (0.8%) from the placebo group expired.

The drug will be examined in more vigorous trials even if accelerated approval is granted by the FDA. Traditional approval will only be granted if the trials show a clinical benefit from the drug. However, if no benefits are revealed, the drug could be taken off the market by the FDA.

According to the Alzheimer’s Association, over 300 treatments for Alzheimer’s are in the clinical trial stage. The first documentation of the disease was in 1906 after Dr. Alois Alzheimer came across brain tissue changes in a woman who had a loss of memory, unpredictable behaviors, and language issues. Over 6M adults in the U.S. suffer from the disease.

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