Biogen recently stated that its investigational treatment for early Alzheimer’s disease (AD), aducanumab, has been accepted into the Priority Medicines (PRIME) program of the European Medicines Agency (EMA).
The goal of PRIME is to create treatments and make them available to patients much faster than traditional programs. Projects included in this program receive special support from the EMA as the investigational medicines are developed. The program focuses on diseases that do not have any treatments -- or those in need of improved treatment options.
Treatments included in PRIME must show that there is significant potential to become major therapeutic advances for unmet medical needs. Based on the outcomes from the phase-1b placebo-controlled study, patients with mild or prodromal Alzheimer’s disease experienced benefits from the treatments.
“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,” Alfred Sandrock, executive vice president and chief medical officer at Biogen, said. “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.”
