Biogen-Eisai's potential Aduhelm sequel drug secured speedy review by FDA
Biogen and Eisai’s Alzheimer’s disease treatment-in-waiting, lecanemab, has been secured a fast-track tag by the FDA, setting up a potentially swift path through the regulatory process.
The drug is the next in line behind the pair’s approved therapy Aduhelm, which secured a yes under the agency's accelerated review pathway back in June. The decision has proven controversial for Biogen, which has struggled to launch the drug and lately decreased the price to half to catch up on boosting sales.
However, Biogen and Eisai have requested the FDA for a similarly accelerated review of lecanema...