Biogen (BIIB) and Eisai Announce FDA's 3-Month Extension of Review Period for BLA for Aducanumab
- Wall St ends lower as investors await earnings, inflation data
- Microsoft (MSFT) announces $19.7 billion acquisition of Nuance (NUAN)
- Alibaba (BABA) Gets a Record $2.8 Billion Anti-Monopoly Fine, Shares Soar as a 'Major Overhang' is Lifted
- Tesla (TSLA) Upgraded to 'Buy' at Canaccord Genuity and PT Raised by 155%, as it 'Holds a Several-Year Lead' in EV While Storage Business Accelerates
- Dollar drops as traders prepare for inflation data
Get instant alerts when news breaks on your stocks. Claim your 1-week free trial to StreetInsider Premium here.
(Updated - January 29, 2021 7:35 AM EST)
Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period by three months for the Biologics License Application (BLA) for aducanumab, an investigational treatment for Alzheimer’s disease. The updated Prescription Drug User Fee Act (PDUFA) action date is June 7, 2021.
As part of the ongoing review, Biogen submitted a response to an information request by the FDA, including additional analyses and clinical data, which the FDA considered a Major Amendment to the application that will require additional time for review.
“We are committed to working with the FDA as it completes its review of the aducanumab application,” said Michel Vounatsos, Chief Executive Offer at Biogen. “We want to thank the FDA for its continued diligence during the review.”
Biogen submitted the aducanumab BLA to the FDA in July 2020. The FDA accepted the BLA in August 2020 and granted Priority Review.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Allogene Therapeutics (ALLO), SpringWorks Therapeutics (SWTX) Report First Patient Dosing in Phase 1 Study Evaluating ALLO-715 in Combination with Nirogacestat in Patients with R/R Multiple Myeloma
- SAGE Therapeutics (SAGE), Biogen (BIIB) Announce SAGE-324 Phase 2 Placebo-Controlled KINETIC Study in Essential Tremor Met Primary Endpoint
- Genmab A/S (GMAB) and Seagen (SGEN) Announce U.S. FDA Filing Acceptance for Priority Review of Tisotumab Vedotin BLA for Patients with Recurrent or Metastatic Cervical Cancer
Create E-mail Alert Related CategoriesCorporate News, FDA, Hot Corp. News, Hot FDA News, Management Comments
Related EntitiesTwitter, PDUFA, FDA
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!