Biogen, Eisai gun for an approval of another Alzheimer’s drug

Sept. 28, 2021

On the heels of their Aduhelm win, Japan-based Eisai Co. and its partner, Biogen, are wasting no time attempting to score a nod for another Alzheimer’s drug.

Just like Aduhelm, the candidate now in question, lecanemab, was shown in trials to clear amyloid plaques in the brain and slow cognitive decline.

But the idea that reducing amyloid buildup will provide a significant benefit to Alzheimer’s patients remains a question of heated debate — and lecanemab is still in phase 3 trials. Yet, feeling the momentum of the Aduhelm nod and armed with positive phase 2 data, the companies started the application process for an accelerated approval of the drug this week.

According to Reuters, Eisai plans to wrap up the application process within a few months. Because lecanemab was granted breakthrough status, the drug will be eligible for priority review.