Biogen Alzheimer’s treatment accepted into EMA’s PRIME scheme
pharmafile | June 2, 2016 | News story | Research and Development, Sales and Marketing | Alzheimer's, Biogen, EMA, PRIME, accelerated approval
Biogen (NASDAQ: BIIB) has announced that the European Medicines Agency (EMA) has accepted its investigational treatment for Alzheimer’s disease, aducanumab, onto the PRIME program.
The PRIME (or Priority Medicines) program is designed to bring treatments to patients faster with the EMA providing a range of supports to the development of new medicines for diseases with little or no effective treatments.
Investigational treatments must demonstrate some therapeutic advantage in areas of unmet medical need and aducanumab was accepted onto the PRIME scheme after positive results in a Phase Ib study of the drug in patients with prodromal or mild Alzheimer’s disease.
Biogen will receive EMA assistance, which includes advice at key development milestones and the potential for accelerated assessment of a marketing authorisation application. Aducanumab is currently in two late-stage Phase III trials which will examine if the drug can slow cognitive impairment and the progression of disability in people with early Alzheimer’s disease.
Alfred Sandrock, chief medical officer at Biogen, says: “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 treatments 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.”
Sean Murray
Related Content
Biogen’s high-dose Spinraza regimen receives European Commission approval for spinal muscular atrophy
Biogen’s Spinraza (nusinersen) has received approval from the European Commission (EC) as a new high-dose …
Rethinking oncology trial endpoints with generalised pairwise comparisons
For decades, oncology trials have been anchored to a familiar set of endpoints. Overall survival …
Lilly’s drug for early Alzheimer’s shows promising results
Eli Lilly (Lilly) has announced positive new data from the long-term extension of its phase …
