"Now, Biogen is betting that aducanumab can juice its prospects. The drug is a monoclonal antibody derived from the immune cells of elderly people with no or unusually slow cognitive decline. Researchers designed it to clear from the brain a sticky substance called beta amyloid that is thought by many scientists to contribute to Alzheimer's disease.
Aducanumab's outlook appeared dire in March 2019 when Biogen halted two late studies of the drug after determining it was statistically unlikely to provide a benefit over a placebo. The news caused Biogen shares to sink by 29%, and the company shed $18 billion in market value. Some researchers said failure of aducanumab and other experimental therapies targeting beta amyloid pointed to the need to better understand the biology of Alzheimer's and find other possible drug targets.
Yet the company stunned the investor and scientific communities several months later when it resurrected the drug. Biogen said in October 2019 that it would seek approval for the medicine after analyzing new data from the discontinued trials showing that it appeared to slow cognitive decline compared with placebo in one of the trials. The drug failed to show a benefit in the second study, but Biogen says this is likely because fewer patients received the highest dose of aducanumab.
The FDA faces a deadline of March 7, 2021, to make a decision on aducanumab. If the drug is approved, the financial impact on the U.S. health-care system could be massive." [1]
For Lithuania - even bigger. You will regret dismissing Veryga, who knew how to fight such companies.
1. Biogen's Dementia Drug Gets FDA Lift
Walker, Joseph. Wall Street Journal, Eastern edition; New York, N.Y. [New York, N.Y]05 Nov 2020: B.1.
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