FDA committee says Leqembi shows benefits in early Alzheimer’s

The FDA Peripheral and Central Nervous System Drugs Advisory Committee unanimously voted on June 9 that Leqembi showed clinical benefit in early Alzheimer’s disease, the Alzheimer’s Drug Discovery Foundation said in a press release.

The FDA granted Leqembi (lecanemab, Eisai/Biogen) accelerated approval in early January, and shortly after Eisai submitted a supplemental Biologics License Application to the FDA to support the conversion of its accelerated approval to traditional.

The Alzheimer’s Drug Discovery Foundation (ADDF) said in its release that the FDA committee’s vote paves “the way for a traditional approval of the drug.

“This milestone comes just ahead of its July 6 PDUFA date, and, if approved, Leqembi will be the first-ever disease-modifying treatment for Alzheimer’s to receive full approval,” the release said.

“We are encouraged by the FDA advisory committee’s decision to endorse Leqembi, but we recognize that the mission to develop effective treatments for all patients with Alzheimer’s disease is far from over,” ADDF co-founder and chief science officer Howard Fillit, MD, said in the release. “While this is an exciting step forward, our understanding of the biology of aging tells us we will need multiple therapies that target novel pathways and can be used in combination with other drugs, like anti-amyloids, for a precision medicine approach.”

Fillit noted in the release that more than three-fourths of the drugs currently in clinical development target novel pathways.