After winning FDA approval for the controversial Alzheimer’s drug Aduhelm (aducanumab) in June 2021, Biogen (Nasdaq:BIIB) has encountered a string of setbacks.
Most recently, the company has decided to yank its applications for market approval after the European Medicines Agency (EMA) recommended the refusal of the marketing authorization for Aduhelm in December 2021.
At that time, Biogen announced that it would fight the decision.
In April, the company notified EMA that its decision to withdraw its application was “based on interactions with the CHMP [Committee for Medicinal Products for Human Use] indicating that the data provided thus far would not be sufficient to support a positive opinion on the marketing authorization of Aduhelm (aducanumab).”
“We are thankful to the patients, caregivers and physicians that supported the re-examination process as part of the EMA review,” said Dr. Priya Singhal, head of global safety and regulatory sciences and interim head of R&D at Biogen, in a press release. “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.”
Sales of the drug in the U.S. have sputtered since launch and the CMS’s decision to limit coverage of it to clinical trial participants have been a further headwind.
BIIB shares dropped 3.85% to $209.99. In June 2021, the company’s share price almost reached $400.
Biogen has announced a series of measures to defray costs, including restructuring and a decision to sell its equity stake in Samsung Bioepis joint venture for up to $2.3 billion.