A European Medicines Agency panel voted against the marketing application for aducanumab, as Biogen looks to provide its controversial Alzheimer's disease treatment to patients in Europe.
Following an oral explanation during the November Committee for Medicinal Products for Human Use (CHMP) meeting, Biogen received a negative trend vote on its application for aducanumab 100 mg/mL concentrate solution for infusion.
The U.S. FDA gave the drug, now marketed as Aduhelm, the green light back in June — amid much debate over its effectiveness — making it the first new treatment for the memory-robbing disease in nearly 20 years.
Recently, at the Clinical Trials on Alzheimer’s Disease conference, Biogen announced new phase 3 findings that provide further evidence of aducanumab’s effect on lowering amyloid beta plaque and downstream tau pathology, the two defining pathologies of Alzheimer’s disease.
A formal opinion on the Marketing Authorization Application in the EU is expected to be adopted at CHMP's December meeting, taking place Dec. 13-16.
