Biogen To Seek Re-examination Of Negative Opinion By EMA For Its 'aducanumab'

(RTTNews) - Biogen Inc. (BIIB), an American company focused on the therapies for the treatment of neurological diseases said it intends to seek re-examination of negative opinion adopted by European Medicines Agency or EMA for the company's Alzheimer's drug aducanumab.

EMA's Committee for Medicinal Products for Human Use (CHMP) opted for a negative opinion on Biogen's Marketing Authorization Application (MAA) for aducanumab, for the treatment of the early stages of Alzheimer's disease in the European Union.

Priya Singhal, Head of Global Safety & Regulatory Sciences at Biogen, commented: "…As part of the re-examination process, we will seek to address the CHMP's grounds for refusal, with the goal of making this medicine available in the EU. European patients deserve access to innovative treatments for Alzheimer's disease."