Oct. 30 Quick Takes: Aducanumab heads to EMA; plus Boehringer, Arcus-AZ, Tricida

EMA accepts aducanumab MAA for review
Biogen Inc. (NASDAQ:BIIB) and Eisai Co. Ltd. (Tokyo:4523) said the EMA accepted for review an MAA for Alzheimer’s disease candidate aducanumab. The anti-amyloid mAb will undergo standard review, putting a European decision months behind the U.S. FDA will hold an advisory committee meeting on Nov. 6 to discuss aducanumab, which has priority review in the U.S. and a March 7 PDUFA date.

Boehringer starts Phase II for COVID complication
Boehringer Ingelheim GmbH has started a double-blind Phase II trial of BI 764198 to prevent respiratory deterioration in hospitalized COVID-19 patients ages 50 and older who are receiving oxygen. The primary endpoint is the proportion of patients who are alive and free of ventilation on day 29. BI 764198 is an oral inhibitor of receptor-operated cation channel TRPC6, which can be activated by reactive oxygen species produced in response to airway injury...