Biogen, Eisai Alzheimer's drug lecanemab gets 'fast track' designation from FDA

said on Thursday the U.S. Food and Drug Administration had granted "fast track" designation to their experimental therapy lecanemab for the treatment of early Alzheimer's disease.The drug works in a similar manner to Biogen's Aduhelm and gets rid of sticky deposits of a protein called amyloid beta from brains of patients in the initial stages of the disease to mitigate its impact.

Biogen and Eisai have jointly developed three experimental drugs for the brain-wasting disease, which affects millions around the world. Adulhelm's development was nearly abandoned after disappointing trial results in 2019, but Biogen revived it after reviewing data that showed higher doses of the drug could slow disease progression.

Adulhelm, known scientifically as aducanumab, was dealt a setback in Japan on Wednesday when a health ministry panel said that inconsistent trial results made it difficult to determine its efficacy.Reporting by Vishal Vivek in Bengaluru, Rocky Swift in Tokyo; Editing by Vinay DwivediSubscribe for our daily curated newsletter to receive the latest exclusive Reuters coverage delivered to your inbox.

Source: Healthcare Press (healthcarepress.net)

What was the p-value in the studies...50? Oh, but it's biogen , so it must be approved...no matter how toxic.

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