A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has unanimously voted in support of Eisai and Biogen’s Leqembi and its clinical benefit in patients with early Alzheimer’s disease, raising the drug’s full approval prospects.
All six members of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) voted in support of the Phase III Clarity AD (NCT03887455) data being adequate to verify the clinical benefit of Leqembi as an Alzheimer’s disease treatment, based on a 9 June Biogen press release.
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While the FDA granted Leqembi accelerated approval at the start of the year, the advisory committee’s verdict boosts the drug’s full approval prospects as it nears the 6 July PDUFA date. Although the FDA does not need to follow AdCom verdicts, they are still considered as the agency mulls about its decision.
The Clarity AD study clearly demonstrated the clinical benefit of Leqembi, said Dr. Robert Alexander, research professor at the University of Arizona’s College of Medicine, who voted in favour of Leqembi at the 9 June meeting.
The evidence for clinical benefit was “very clear”, said Dr. Merit Cudkowicz, Julieanne Dorn professor of neurology at Harvard University’s Medical School. Regarding discussions on the therapy’s applicability to patients , Cudkowicz noted the data showed clinically meaningful changes. In other words, even a “couple more months in a higher functioning state” can be considered clinically meaningful, she said.
“As a patient advocate, I have to step back ten years [back] when I was the primary caregiver for my father. Even with the risk, and there are significant concerns there, I can’t tell you what I would’ve paid to have this option,” said patient representative Colette Johnston.
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By GlobalDataThe two companies announced that the Clarity AD trial met both the primary and all key secondary endpoints in September 2022. The trial reported a statistically significant reduction of clinical decline in the patients. However, side effects known as amyloid-related imaging abnormalities, which often involve brain swelling, were also reported, and consequently the treatment has a warning on this specific side effect on its label.
Also known as lecanemab, Leqembi is a humanised immunoglobulin gamma 1 monoclonal antibody targeted at aggregated soluble and insoluble forms of amyloid-beta, per the company’s description.
Leqembi is the second drug developed by Biogen and Eisai for the treatment of Alzheimer’s disease. The two companies previously developed aducanumab, an Alzheimer’s drug marketed as Aduhelm which attracted significant controversy over its accelerated approval in June 2021. Notably, an FDA AdCom voted largely against Aduhelm in November 2020. Several members of an FDA AdCom resigned following the drug’s subsequent approval. Additionally, the amyloid theory, a hypothesis according to which the build-up of amyloid-beta plaque causes Alzheimer’s disease, has also received its share of criticism. In May 2022, Biogen announced its plans to “substantially eliminate” the commercial infrastructure for Aduhelm, with Biogen also taking further cost-reductions steps.
The two companies had announced their collaboration agreement to develop and commercialise Alzheimer’s disease treatments in March 2014.
