Biogen and Eisai Announce EMA Acceptance of Marketing Authorization Application for Aducanumab in Alzheimer's Disease
Eisai
Pharmaceutical Product R&D and Manufacturer
Biogen
New Drug Developer
European Medicines Agency
The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), located in London. It began operations in 1995. The agency is responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. By ensuring that all medicines available on the EU market are safe, effective, and of high quality, the EMA protects public and animal health in the 28 EU Member States and countries of the European Economic Area.
On November 19, Biogen and Eisai announced that the European Medicines Agency (EMA) had accepted the Marketing Authorization Application (MAA) for aducanumab, an investigational therapy for Alzheimer’s disease, and would review it according to the standard timeline.
Clinical data from patients with mild cognitive impairment due to Alzheimer’s disease and those with Alzheimer’s disease indicate that aducanumab treatment removes beta-amyloid and yields superior clinical outcomes. If approved, aducanumab would become the first therapy capable of slowing the decline of clinical symptoms in Alzheimer’s disease.
It is reported that the U.S. FDA has also accepted the marketing authorization application for aducanumab and granted it Priority Review designation. Under the Prescription Drug User Fee Act (PDUFA), the FDA’s target review date was March 7, 2021.
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