T3 Trading chief strategist Scott Redler gives his market outlook on biotech investing.
A third member of a panel of outside advisers to the U.S. Food and Drug Administration has resigned in protest over the agency's decision to approve Biogen Inc's Alzheimer's disease treatment despite the committee's recommendation against doing so.
Aaron Kesselheim, a Professor of Medicine at Harvard Medical School who had served on the FDA’s advisory committee for nervous system drugs since 2015, told Reuters on Thursday he was stepping down from the panel.
GET FOX BUSINESS ON THE GO BY CLICKING HERE
"My rationale was that the FDA needs to re-evaluate how it solicits and uses the advisory committees ... because I didn’t think that the firm recommendations from the committee in this case ... were appropriately integrated into the decision-making process," Kesselheim said in an email.
He cited FDA's decision to approve Sarepta Therapeutic Inc's drug, eteplirsen, for Duchenne muscular dystrophy in 2016 as another example of the regulator approving a drug against the recommendations of its advisory committee.
Stat News first reported his departure.
MEDICARE COPAYS FOR NEW ALZHEIMER'S DRUG COULD SOAR
On Tuesday, a member of the advisory group who voted against the approval, Washington University neurologist Dr. Joel Perlmutter, resigned from the committee, citing the FDA's approval of Aduhelm.
Mayo Clinic neurologist Dr. David Knopman said he resigned on Wednesday.
| Ticker | Security | Last | Change | Change % |
|---|---|---|---|---|
| BIIB | BIOGEN, INC. | 414.71 | +7.77 | +1.91% |
The 11-member committee voted nearly unanimously in November that Biogen's drug should not be approved, citing inconclusive evidence that the drug was effective.
CLICK HERE TO READ MORE ON FOX BUSINESS
The FDA on Monday gave the drug "accelerated approval," based on evidence that it can reduce a likely contributor to Alzheimer’s, rather than proof of a clear benefit against the disease.
(Reporting by Julie Steenhuysen and Carl O'Donnell; editing by Grant McCool)
Article From & Read More ( Third member of US FDA advisory panel resigns over Alzheimer's drug approval - Fox Business )https://ift.tt/2ThDPuw
Business
Bagikan Berita Ini
0 Response to "Third member of US FDA advisory panel resigns over Alzheimer's drug approval - Fox Business"
Post a Comment