- Biogen Inc BIIB has decided to withdraw the European marketing authorization application for its troubled Alzheimer's drug, aducanumab, after failing to convince the regulator of its benefits.
- The drugmaker said the move follows its interactions with the EMA's Committee for Medicinal Products for Human Use (CHMP), indicating that the data provided thus far would not be sufficient to support a favorable opinion.
- In December, the agency had rejected the drug, and Biogen had sought a re-examination of its decision.
- Also Read: EMA's Committee Gives Thumbs Down To Biogen's Controversial Alzheimer's Drug, As Expected.
- "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," said Priya Singhal, interim head of R&D at Biogen.
- Related: Biogen's Alzheimer's Drug Aduhelm Medicare Coverage Restricted To Just Clinical Trials, CMS Finalizes.
- Price Action: BIIB shares are down 3.16% at $211.50 during the market session on the last check Friday.
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