Biogen’s Alzheimer’s drug approved by FDA, first new therapy in nearly two decades

submitted by Drewski from (cnbc.com)

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[–]hennaojichan 1 insightful - 1 fun1 insightful - 0 fun2 insightful - 1 fun -  (0 children)

It seems that the big story here is the stock price, not the millions of people who might be helped by this medicine. Follow the money. Thanks.

[–]Alan_Crowe 1 insightful - 1 fun1 insightful - 0 fun2 insightful - 1 fun -  (0 children)

The controversy here is that it might not be a therapy. After two decades of drugs failing in trials, the FDA has watered down the criteria for approval. The drug is supposed to treat Alzheimer's Disease by clearing away the amyloid protein. The traditional end point for a trial is whether it treats Alzheimer's Disease; that is: does it have an effect on the disease. Drug industry jargon calls having an effect on the disease efficacy.

Derek Lowe, a drug industry insider, explains here

The agency seems to have approved it based on its demonstrated ability to clear beta-amyloid, and is asking Biogen to run a confirmatory trial to show efficacy.