FDA Advisory Committee Indicates Support for Alzheimer’s Drug Leqembi

This follows an FDA ruling from earlier this year

Brain scan
A new treatment for Alzheimer's disease has gotten encouraging signals from the FDA.
Getty Images

In January of this year, the U.S. Food and Drug Administration approved the drug Leqembi for accelerated approval. As the agency noted at the time, this drug differed from earlier treatments in the way that it addressed the disease. “This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease,” said Dr. Billy Dunn of the FDA’s Center for Drug Evaluation and Research in a statement.

Now, Leqembi has gotten one step closer to being more widely available. As The Washington Post reports, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has indicated its support for the encouraging conclusions reached following a clinical trial of the drug.

As per an announcement from Biogen, one of two companies collaborating on developing Leqembi — the other is Eisai — the drug is intended for patients experiencing “mild cognitive impairment or [the] mild dementia stage of disease.” The Post‘s report points out that the drug has its limitations; it can slow progression of Alzheimer’s by between five and six months, but cannot undo existing damage to a patient’s brain.

Director Martin Campbell Explains How He Made an Action Movie About Alzheimer’s
“Memory” features Liam Neeson as a hitman in the early stages of the disease

As the Post‘s coverage details, there remains some tension related to the drug. These largely concern its side effects, and whether the potential health risks outweigh Alzheimer’s patients having more time to spend with loved ones. There’s also the question of whether or not Medicare will cover the drug; according to the Post‘s reports, a year’s supply of Leqembi will cost around $26,500. The committee’s approval sounds like a promising step forward — but it’s far from the final step to getting this treatment to everyone who needs it.

The InsideHook Newsletter.

News, advice and insights for the most interesting person in the room.