FDA Advisory Panel Backs Leqembi for Alzheimer's Treatment

by Staff Writer
June 13, 2023 at 9:05 AM UTC

Recent FDA advisory panel support for Leqembi, an Alzheimer's drug, highlights its potential clinical benefits for early-stage patients, despite associated risks.

Clinical Relevance: Options for early Alzheimer’s treatment are about to expand

  • FDA advisory panel supports Alzheimer’s drug Leqembi for full approval.
  • Lecanemab, marketed as Leqembi, is an anti-amyloid that shows promise in slowing cognitive decline in early-stage Alzheimer’s patients.
  • The drug carries risks of brain swelling and bleeding, requiring careful patient evaluation before prescribing.

A US Food and Drug Administration (FDA) advisory panel unanimously backed the Alzheimer’s drug Leqembi last week, setting it up for full approval.

The Path to Approval

In January, the FDA granted accelerated approval for lecanemab, marketed under the name Leqembi. The anti-amyloid treatment showed promise in slowing the progression of cognitive decline in patients in the early stages of Alzheimer’s disease.

The drug met both the primary and all key secondary endpoints for the target patient population in the phase 3 data from the Clarity AD global clinical trial. Results from the study, which were statistically significant, were published in the New England Journal of Medicine.

“The FDA Advisory Committee’s support for traditional approval of Leqembi for people with early Alzheimer’s is welcomed and celebrated by the Alzheimer’s Association,” said Joanne Pike, president and CEO of the Alzheimer’s Association in a statement. “With this action, we are one step closer to enabling more people living with Alzheimer’s to retain more of their capabilities intact, allowing them to do the things they want to do and love to do best.”

Cautions, Next Steps

However, the drug does increase the risk of swelling and bleeding in the brain. The current prescriber documentation emphasizes the need for real-world evidence and long-term safety data collection. Eisai, the maker of the drug, explicitly states that the drug is suitable only for patients in the early stages of the neurodegenerative disease. The company recommends testing patients before administering the drug to determine if there is a buildup of amyloid proteins in the brain.

Despite these caveats, Pike stated that the association fully agrees with the FDA advisory committee. She says that Leqembi’s clinical benefits that outweigh its risks. In a category still light on options, Pike emphasized that Americans living with Alzheimer’s disease “deserve access to FDA-approved therapies without barriers, similar to people with cancer, heart disease, and HIV/AIDS.”

The FDA has granted Priority Review to advance Leqembi to the next phase of traditional approval application, which involves a full FDA review. For the treatment to receive full agency approval, Eisai must complete this action by July 6, 2023. The company has not yet released proposed pricing information.

Looking to the Future

More than six million Americans of all ages live with Alzheimer’s. The condition has no cure. Current treatments offer limited improvement for symptoms such as memory deterioration and loss of function.

The FDA Peripheral and Central Nervous System Drugs Advisory Committee, which voted on the drug, expressed the goal of delivering multiple therapies for an individualized approach in Alzheimer’s.

“In today’s pipeline, over three quarters of drugs in clinical development target novel pathways, priming the field for the next generation of drugs that address a variety of underlying factors,” said Howard Fillit, MD, co-founder, and chief science officer of the committee.

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