Published on 18 Nov 2021 on Zacks via Yahoo Finance
Biogen BIIB and its Japan-based partner Eisai announced that they received a negative trend vote from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) related to their marketing authorization application for their Alzheimer’s disease (AD) drug, aducanumab, in Europe.
The CHMP’s negative trend vote was based on an oral explanation from Biogen in a meeting held earlier this month. Although the CHMP will provide its formal opinion in December, it is expected that it will maintain its stance and will recommend against the drug’s approval. Meanwhile, Biogen plans to engage in discussions with the EMA and the CHMP for resolving the issues that led to a negative trend vote.
We note that Biogen had a hard time getting approval for the drug in the United States as well. After much controversy, the FDA granted accelerated approval to aducanumab in June, largely based on its ability to remove beta amyloid seen in late-stage studies. However, it is still uncertain whether the reduction in beta amyloid leads to improvement in cognition. The drug is marketd as Aduhelm in the United States. Aduhelm’s FDA approval, despite an FDA advisory committee voting against it, faced a lot of criticism, due to the drug’s mixed efficacy results. The FDA approval is also for patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia but not for patients with earlier or later stages of the disease.