FDA Advisory Committee Supports Biogen and Eisai’s Alzheimer’s Drug, Leqembi

Introduction:

In a significant development, a committee of expert advisors to the U.S. Food and Drug Administrator has endorsed for full approval of an Alzheimer’s disease drug developed by Biogen Inc. in collaboration with Eisai. The committee’s unanimous 6-0 vote concluded that Leqembi, the drug in question, demonstrated clinical benefit for patients, meeting the prerequisite for full approval. While the FDA’s final decision is expected by July 6, it typically aligns with the recommendations of its advisory committees. This endorsement holds great potential for both Biogen and Eisai, as it could replace the drug’s current conditional “accelerated approval” status and expand its commercial reach.

Unlocking Leqembi’s Commercial Potential:

Previously, Leqembi was only available under the conditional “accelerated approval” and limited to patients enrolled in randomized clinical trials. Medicare coverage was restricted by the Center for Medicare and Medicaid Services (CMS) last April, affecting reimbursement for drugs targeting amyloid proteins, including Leqembi and Biogen and Eisai’s other Alzheimer’s drug, Aduhelm. As a result, access to Leqembi and sales have been significantly constrained, considering the high number of Alzheimer’s patients relying on Medicare coverage. However, if granted full approval, Leqembi would replace the conditional approval and potentially expand its market accessibility.

Implications of Full Approval:

The endorsement by the advisory committee carries the possibility of transforming Leqembi’s commercial landscape. With full approval, Medicare coverage for the drug would likely be extended, allowing a wider range of patients to benefit from its therapeutic effects. Biogen and Eisai have collaborated on Leqembi, with Eisai handling its commercialization. Up until now, the companies have generated approximately $18 million from Leqembi, compared to just a few million from Aduhelm. This disparity underscores the impact of CMS’ coverage decision on the sales potential of these drugs.

CMS and Medicare Coverage:

Recent news from CMS brings hope for increased coverage. CMS announced that Medicare would cover Leqembi as soon as it receives full approval from the FDA. However, certain conditions will be attached to this coverage. CMS intends to require uploading patient data to a national registry to assess the real-world efficacy of Leqembi continually. Clinical trials have shown that the drug resulted in a 27% reduction in cognitive and functional decline over an 18-month period.

Conclusion:

The positive endorsement from the FDA advisory committee represents a significant milestone for Biogen and Eisai’s Alzheimer’s drug, Leqembi. If granted full approval, the drug could see a substantial expansion in its commercial reach and improved Medicare coverage, positively impacting the lives of Alzheimer’s patients. The FDA’s final decision is anticipated in the coming weeks, and it is expected to align with the advisory committee’s recommendations. The potential success of Leqembi marks a significant step forward in the ongoing battle against Alzheimer’s disease.