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Biogen Says EU Medicines Agency Accepted Its Investigational Alzheimer's Disease Treatment Aducanumab

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Biogen Inc. (NASDAQ: BIIB) revealed that aducanumab, its investigational treatment for early Alzheimer's disease (AD), was accepted by the European Medicines Agency's (EMA) PRIority MEdicines (PRIME) program. According to the company, PRIME objective was to bring treatments to patients faster by improving the EMA's support for the development of investigational medicines for diseases without available treatment or in need of better treatment options.

Biogen said that with the help of the PRIME program it would gain access to improved support from EMA. This included its advice at key development milestones and the potential for accelerated assessment of a marketing authorization application (MAA).

The company's EVP and CMO, Alfred Sandrock, commented, "Alzheimer's disease is a debilitating condition affecting a growing number of patients and their loved ones, and there is an urgent need for new effective treatment for this disease. Aducanumab's acceptance into the PRIME program is a significant benefit to its development and to the European Alzheimer's disease community. We look forward to collaborating with the EMA on development plans and potential accelerated assessment of aducanumab with the hope of bringing effective treatment to patients as soon as possible."

The company said investigational treatments accepted into PRIME must demonstrate potential for a major therapeutic advantage in areas of unmet medical need. The company added that its Aducanumab was accepted into PRIME based on results from the Phase 1b placebo-controlled trial of aducanumab in patients with prodromal or mild Alzheimer's disease.

Biogen said Aducanumab was being evaluated in two global Phase 3 studies, ENGAGE and EMERGE, which are designed to evaluate its safety and efficacy in slowing cognitive impairment and the progression of disability in people with early Alzheimer's disease.

 

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