Biogen’s new Alzheimer’s therapy accepted into EMA PRIME programme

Biogen has announced that its new Alzheimer's disease therapy aducanumab has been accepted into the European Medicines Agency's (EMA's) Priority Medicines (PRIME) programme.

The PRIME initiative is designed to help bring treatments to patients faster by enhancing the EMA's support for the development of investigational medicines. It mostly includes diseases that lack readily available treatments, or those in need of better therapy options.

Aducanumab is an investigational treatment for early Alzheimer's disease that has demonstrated potential in a phase Ib placebo-controlled study in patients with prodromal or mild Alzheimer's.

Through the PRIME programme Biogen will receive advice at key development milestones and the potential for accelerated assessment of a marketing authorisation application.

Dr Alfred Sandrock, executive vice-president and chief medical officer at Biogen, said: "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."

This comes after the company received European regulatory approval for Flixabi, a new biosimilar referencing Remicade, earlier this month.