On Monday, the FDA accepted Eisai Co., Ltd. ESALY and Biogen Inc’s BIIB Biologics License Software (BLA) for lecanemab-irmb (Leqembi) subcutaneous autoinjector (SC-AI) for weekly upkeep dosing.
Leqembi is indicated for Alzheimer’s illness in sufferers with Delicate Cognitive Impairment or delicate dementia stage of the illness.
A Prescription Drug Person Price Act (PDUFA) motion date is August 31, 2025.
The BLA is predicated on information from the Readability AD (Research 301) open-label extension (OLE) and modeling of noticed information.
Additionally Learn: Biogen Downgraded On Pipeline Setbacks And Leqembi Gross sales Slowdown
If the FDA approves Leqembi subcutaneous upkeep dosing, Leqembi would be the solely therapy for AD that may be administered subcutaneously at house utilizing an autoinjector.
The injection course of is predicted to take, on common, 15 seconds. As a part of the SC-AI 360 mg weekly upkeep routine, sufferers who’ve accomplished the biweekly intravenous (IV) initiation part, the precise interval below dialogue with the FDA, would obtain weekly doses anticipated to take care of the medical and biomarker advantages.
Lengthy-term three-year Leqembi information offered on the Alzheimer’s Affiliation Worldwide Convention (AAIC) 2024 recommend that early and persevering with therapy might delay the good thing about remedy even after plaque is cleared from the mind.
Eisai serves because the lead for lecanemab’s improvement and regulatory submissions globally. Eisai and Biogen co-commercialize and co-promote the product, and Eisai has the ultimate decision-making authority.
On Monday, Biogen submitted an unsolicited bid to amass all the excellent shares of Sage Therapeutics Inc. BIIB, which Biogen doesn’t already personal, for $7.22 per share.
Goldman Sachs analyst Salveen Richter believes the proposal makes strategic sense, contemplating the monetary success of the Zurzuvae launch for postpartum despair (PPD).
Value Motion: BIIB inventory closed at $150.18 on Monday.
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