|
Wall Street analysts largely believe the panel's near-unanimous
votes against the drug, aducanumab, make it difficult for the
FDA to go against the panel.
"Approving aducanumab, in the face of such an overwhelmingly
negative vote and commentary, is virtually impossible and would
destroy the agency's reputation at a very tenuous time for the
regulator, ahead of potential actions on COVID vaccines," Baird
analyst Brian Skorney said.
The panel on Friday voted "no" to three questions related to
whether a single successful large trial of the drug was enough
evidence of its effectiveness, given the failure of a second
large study.
The FDA is expected to make its decision on aducanumab by March
and is not obligated to follow the recommendations of the panel,
but usually does.
It is uncommon for the FDA to act against the committee,
Jefferies analyst Michael Yee said, adding that it happens less
than 20% of the time.
Bowing to pressure from patient advocates, the agency in 2016
approved a treatment for Duchenne muscular dystrophy from
Sarepta Therapeutics Inc, even though an outside panel of
experts and the agency's own reviewers questioned the drug's
efficacy. (https://reut.rs/2IaXM17)
"The FDA can do what it wants," Stifel analyst Paul Matteis
said, adding that the vote against Sarepta's Exondys 51 was
obviously better than the 0-10-1 against aducanumab.
If approved, aducanumab would become the first new treatment for
Alzheimer's in decades and the first that appears to be able to
slow progression of the fatal, mind-wasting condition,
potentially bringing in billions of dollars in sales for Biogen.
(Reporting by Manas Mishra and Manojna Maddipatla in Bengaluru;
Editing by Shounak Dasgupta)
[© 2020 Thomson Reuters. All rights
reserved.] Copyright 2020 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.
Thompson Reuters is solely responsible for this content.
|
|
