Biogen announced that aducanumab, its investigational treatment for early Alzheimer’s disease (AD), was accepted into the European Medicines Agency’s (EMA) PRIority MEdicines (PRIME) program. PRIME aims to bring treatments to patients faster by enhancing the EMA’s support for the development of investigational medicines for diseases without available treatment or in need of better treatment options.
“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, M.D., Ph.D., executive vice president and chief medical officer at Biogen. “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.”
Investigational treatments accepted into PRIME must demonstrate potential for a major therapeutic advantage in areas of unmet medical need. Aducanumab was accepted into PRIME based on results from the Phase 1b placebo-controlled study of aducanumab in patients with prodromal or mild Alzheimer’s disease.
Through the PRIME 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 authorisation application (MAA).
Aducanumab is currently 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.
For more information about the Phase 3 studies, including information about participating centers, visit www.ClinicalTrials.gov (NCT02477800 or NCT02484547).
Filed Under: Drug Discovery