Biogen Withdraws European Application For Alzheimer’s Drug
2022.04.22 20:31
By Sam Boughedda
Investing.com — Biogen Inc (NASDAQ:BIIB) shares fell more than 3% Friday after the company said it has pulled its Marketing Authorization Application (MAA) in Europe for aducanumab, its drug for the treatment of the early stages of Alzheimer’s disease.
The company said it withdrew the application following interactions with EMA’s Committee for Medicinal Products for Human Use that indicated the data provided “would not be sufficient to support a positive opinion on the marketing authorization of aducanumab by EMA.”
“We stand by the safety and efficacy of aducanumab, and we look forward to upcoming data readouts to continue to provide important information on the science of this new class of compound,” stated Priya Singhal, Head of Global Safety and Regulatory Sciences and interim Head of Research & Development at Biogen.
The drug has already faced issues in the U.S., with controversy over its data and pricing, with two lawmakers calling for an investigation.
Biogen stated that it remains committed to “working towards the goal of bringing new treatment options to people living with Alzheimer’s disease.”
