Eisai completes rolling BLA submission for subcutaneous maintenance dosing of Leqembi® (lecanemab-irmb) in the US
BioAge Labs, Inc. (BIOA)
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Source: PR Newswire
STOCKHOLM, Oct. 31, 2024 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that Eisai has completed the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: Leqembi) subcutaneous autoinjector for weekly maintenance dosing after it was granted Fast Track designation by the FDA. Leqembi is indicated for the treatment of Alzheimer's disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD).The BLA is based on data from the Clarity AD open-label extension (OLE) study and modeling of observed data. If the application is approved by the FDA, the Leqembi autoinjector could be used to administer Leqembi at home or at medical facilities, and the injection process is expected on average to take about 15 seconds. As part of the subcutaneous autoinjector 360 mg weekly maintenance regimen
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- CHMP issues positive recommendation for approval of lecanemab in the EUPR Newswire
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- BioAge Labs Reports Strong Q3 2024 Achievements [Yahoo! Finance]Yahoo! Finance
- Eisai updates Leqembi® outlook for fiscal year 2024 (April 2024 - March 2025). Sales now expected to reach JPY 42.5 billionPR Newswire
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Sec Filings
- 11/14/24 - Form SC
- 11/12/24 - Form SC
- 11/7/24 - Form 10-Q
- BIOA's page on the SEC website