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Biogen-Eisai’s potential Aduhelm sequel drug granted speedy review by FDA

December 27, 2021


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.

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