Scientists furious after FDA authorises drug without solid proof it works
Nearly half of all drugs receiving accelerated approval ultimately got full approval, after an average of about three years
12 June 2021 - 08:00
Chicago — In approving the first new Alzheimer’s drug in nearly 20 years, the US Food and Drug Administration (FDA) is taking its biggest risk yet with a strategy that allows new therapies onto the market without strong evidence that they work, regulatory and scientific experts say.
The Biogen drug, Aduhelm, was authorised based on evidence that it can reduce brain plaques, a likely contributor to Alzheimer’s, rather than proof that it slows progression of the lethal mind-wasting disease...
Would you like to comment on this article?
Sign up (it's quick and free) or sign in now.
Please read our Comment Policy before commenting.
Subscribe now to unlock this article.
Support BusinessLIVE’s award-winning journalism for R129 per month (digital access only).
There’s never been a more important time to support independent journalism in SA. Our subscription packages now offer an ad-free experience for readers.
Cancel anytime.
Questions? Email helpdesk@businesslive.co.za or call 0860 52 52 00. Got a subscription voucher? Redeem it now.