ALL STEM CELLS

Biogen and Eisai’s Alzheimer’s disease treatment-in-waiting, lecanemab, has been granted 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 gained a green light 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 recently slashed the price in half to try to boost sales.

Nonetheless, Biogen and Eisai have asked the FDA for a similarly accelerated review of lecanemab. Their submission got underway in September on a rolling basis, with the companies sending information to the agency as it comes in.

See More : https://www.fiercebiotech.com/biotech/biogen-eisai-s-aduhelm-follow-up-granted-speedy-review-by-fda" target="_blank">fiercebiotech