Sam Boughedda

Biogen Inc (NASDAQ 🙂 shares plunged more than 3% on Friday following the announcement by the company that its Marketing Authorization Application in Europe (MAA) for its treatment for early Alzheimer’s stages, aducanumab (NASDAQ:), was withdrawn.

After discussions with EMA’s Committee for Medicinal Products for Human Use, the company stated it had withdrawn the application. The Committee indicated that the provided data “would not suffice to support a positive opinion by EMA on the marketing approval of aducanumab.”

“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.

Already, the U.S. has faced problems with this drug, including controversy regarding its pricing and data, and two legislators calling for an investigation.

Biogen said that they are still committed to providing new treatments for people with Alzheimer’s.