FDA To Review Under the Skin Weekly Autoinjector For Biogen/Eisai's Alzheimer's Drug Leqembi

On Monday, the FDA accepted Eisai Co., Ltd. ESALY and Biogen Inc’s BIIB Biologics License Application (BLA) for lecanemab-irmb (Leqembi) subcutaneous autoinjector (SC-AI) for weekly maintenance dosing.

Leqembi is indicated for Alzheimer’s disease in patients with Mild Cognitive Impairment or mild dementia stage of the disease.

A Prescription Drug User Fee Act (PDUFA) action date is August 31, 2025.

The BLA is based on data from the Clarity AD (Study 301) open-label extension (OLE) and modeling of observed data.

Also Read: Biogen Downgraded On Pipeline Setbacks And Leqembi Sales Slowdown

If the FDA approves Leqembi subcutaneous maintenance dosing, Leqembi will be the only treatment for AD that can be administered subcutaneously at home using an autoinjector.

The injection process is expected to take, on average, 15 seconds. As part of the SC-AI 360 mg weekly maintenance regimen, patients who have completed the biweekly intravenous (IV) initiation phase, the exact period under discussion with the FDA, would receive weekly doses expected to maintain the clinical and biomarker benefits.

Long-term three-year Leqembi data presented at the Alzheimer’s Association International Conference (AAIC) 2024 suggest that early and continuing treatment may prolong the benefit of therapy even after plaque is cleared from the brain.

Eisai serves as the lead for lecanemab’s development and regulatory submissions globally. Eisai and Biogen co-commercialize and co-promote the product, and Eisai has the final decision-making authority.

On Monday, Biogen submitted an unsolicited bid to acquire all of the outstanding shares of Sage Therapeutics Inc. BIIB, which Biogen does not already own, for $7.22 per share.

Goldman Sachs analyst Salveen Richter believes the proposal makes strategic sense, considering the financial success of the Zurzuvae launch for postpartum depression (PPD).

Price Action: BIIB stock closed at $150.18 on Monday.

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