Saturday, June 15, 2024

Eisai and Biogen Resume FDA Submission for Alzheimer’s Subcutaneous Leqembi After Regulatory Setback

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Eisai and Biogen have reignited their push to gain FDA approval for a new subcutaneous version of their Alzheimer’s drug, Leqembi, following a brief regulatory hurdle. Late Tuesday, the biotech giants announced the initiation of a rolling FDA submission for this under-the-skin formulation of Leqembi, which has already been granted fast-track designation by the agency.

Currently administered via infusion, the new formulation of Leqembi aims to simplify treatment by allowing weekly maintenance doses to be delivered either at home or in medical facilities, after an initial biweekly infused phase. This development could significantly reduce the time patients spend in medical settings and decrease the caregiving burden, potentially lessening the need for frequent hospital visits and nursing care.

Subcutaneous Leqembi Advances Alzheimer’s Treatment Despite Initial Delays

Industry analysts have pointed to the subcutaneous version of Leqembi as a pivotal development that could enhance patient convenience and boost the drug’s sales. Despite receiving full FDA approval last summer, Leqembi’s rollout has been slow, largely due to complex logistics surrounding the diagnosis and treatment of Alzheimer’s disease. As of January 26, only 2,000 U.S. patients were being treated with Leqembi, with an additional 8,000 awaiting treatment.

Eisai’s leadership remains optimistic about accelerating patient access. “As the diagnosis and the treatment pathways are established and implemented, we will be able to administer Leqembi to these patients,” stated Keisuke Naito, Eisai’s global Alzheimer’s disease officer.

The recent regulatory challenge came in early April when the FDA delayed Eisai and Biogen’s submission by requesting additional immunogenicity data on the subcutaneous formulation. Despite this, the partners managed to commence their planned rolling submission based on encouraging phase 3 study data, which showed the subcutaneous injection clearing more amyloid plaque than the infused version.

Alzheimer’s

FDA Fast-Track Aids Leqembi’s Growth in Alzheimer’s Market Amid Competitor Delays

The fast-track designation by the FDA could facilitate more frequent interactions with the agency and possibly lead to an accelerated approval or priority review. This regulatory advantage is timely, especially after the FDA recently postponed its approval decision on Eli Lilly’s competing Alzheimer’s drug, donanemab, giving Eisai and Biogen additional market opportunity.

As part of its strategy to maximize this advantage, Biogen announced a 30% increase in its Leqembi field force in the U.S. and is intensifying direct-to-patient and caregiver-specific marketing efforts. This approach appears to be paying off, as Biogen reported a substantial increase in global Leqembi sales to $19 million in the first quarter of 2024, marking significant growth from the end of 2023.

 

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Resource: Biogen, May 14, 2024

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