(Reuters) -Biogen Inc’s marketing application for its Alzheimer’s disease drug was voted down by a European Medicines Agency (EMA) panel, in the latest blow to the U.S. drugmaker, sending its shares down 3% in trading before the bell.
The negative vote by the panel will be taken into consideration by the EMA, which is not bound to follow its panel’s recommendation, but usually does.
“Given the existing data and controversy attached to the drug, we see no reason why there would be a divergence (in EMA’s decision),” said Wedbush analyst Laura Chico.
The drug, Aduhelm, was approved by U.S. regulators earlier this year despite mixed data, and after an independent panel to the U.S. Food and Drug Administration voted against the approval.
Aduhelm, the first new treatment for the memory-robbing disease in nearly 20 years, has been battling slow uptake in the United States.
The panel, Committee for Medicinal Products for Human Use, will adopt a final opinion at a December meeting, the company said.
(Reporting by Manas Mishra in Bengaluru; Editing by Krishna Chandra Eluri, Anil D’Silva and Shinjini Ganguli)
