Biogen Alzheimer’s Drug Accepted for EMA PRIME

Biogen’s investigational treatment for early Alzheimer’s disease (AD), aducanumab, has been accepted into the European Medicines Agency’s (EMA) PRIority MEdicines (PRIME) program, aimed at accelerating registration of medicines for diseases without available treatment or in need of better treatment options.

Investigational treatments accepted into PRIME must demonstrate potential for a major therapeutic advantage in areas of unmet medical need. Aducanumab’s acceptance was based on results from the Phase 1b placebo-controlled study in patients with prodromal or mild Alzheimer’s disease.

Through the program, Biogen will have access to enhanced support from EMA, including its advice at key development milestones and the potential for accelerated assessment of a marketing authorization application (MAA). Aducanumab is currently being evaluated in two global Phase 3 studies, ENGAGE and EMERGE, designed to evaluate the drug’s safety and efficacy in slowing cognitive impairment and the progression of disability in people with early Alzheimer’s disease.

“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,” said Alfred Sandrock, Biogen’s executive vice president and chief medical officer at. He called  the acceptance into the PRIME program “a significant benefit to its development and to the European Alzheimer’s disease community.”