What's Happening?
Eisai Co. and Biogen Inc. have received U.S. regulatory approval for a new self-injected form of their Alzheimer’s drug, Leqembi. This development allows patients who have completed the initial 18 months of infusions to continue their treatment with a weekly injection at home. The self-injected formulation, named Leqembi Iqlik, will be available starting in October. The list price for the weekly injection is set at $375, totaling $19,500 annually, compared to the infused version costing approximately $26,500 per year. The approval aims to simplify the treatment regimen, which has been complicated by the need for regular infusions and concerns over side effects such as brain swelling and bleeding. The FDA has required Eisai to update prescribing information to include recommendations for earlier MRI screenings to potentially prevent serious outcomes.
Why It's Important?
The approval of the self-injected form of Leqembi is significant as it addresses the complexity and inconvenience associated with the current infusion regimen. This could lead to increased patient adherence and potentially better outcomes for those suffering from Alzheimer’s. The move also represents a strategic effort by Eisai and Biogen to enhance the drug's marketability and accessibility, potentially boosting sales. The drug's safety profile remains a concern, with the FDA highlighting risks of brain swelling and bleeding, necessitating careful monitoring. The development is crucial for both companies as they compete with Eli Lilly & Co.'s Kisunla, another Alzheimer’s treatment, in a growing market.
What's Next?
Eisai and Biogen are working on a self-injected form of Leqembi that can be used from the start of treatment, with plans to file for approval soon. The companies aim to maintain the benefits achieved in the initial treatment phase and prevent the progression of Alzheimer’s. The approval of the self-injected maintenance treatment is expected to pave the way for broader use and acceptance of the drug. As the market for Alzheimer’s treatments expands, competition with other drugs like Kisunla will likely intensify, influencing pricing and treatment strategies.
