Aducanumab, a monoclonal β-amyloid antibody, has been evaluated in several clinical trials on mild Alzheimer’s disease (AD) and mild cognitive impairment, including the ENGAGE, EMERGE and PRIME trials. Since 7 August 2020, Aducanumab has been under priority review at the US Food and Drug Administration (FDA).
On 29 January, Biogen and Eisai have announced that the FDA has extended the review period by three months for the biologics license application for aducanumab. The decision by the FDA on the drug application was expected on March 7, but is now delayed until June 7, 2021.
“We are committed to working with the FDA as it completes its review of the aducanumab application,” said Michel Vounatsos, Chief Executive Officer at Biogen. “We want to thank the FDA for its continued diligence during the review.”
