Another FDA Adviser Resigns In Wake Of Alzheimer’s Drug Approval Decision
The Washington Post and Axios report on the ongoing fallout from the "contentious" decision to approve Aduhelm while CNN covers the costs and side-effects of the new drug. The Cincinnati Enquirer notes it will be available at UC Health and two other Ohio sites.
The Washington Post:
Two Members Of An FDA Advisory Committee Quit After Approval Of Controversial Alzheimer’s Drug
Two members of a Food and Drug Administration advisory panel resigned this week after the agency’s contentious decision to approve an Alzheimer’s drug over the objections of its outside advisers. David S. Knopman, a neurologist at the Mayo Clinic, said Wednesday in an email to The Washington Post that he did not “wish to be part of a sham process” that ultimately resulted in the agency’s approval Monday of Biogen’s Aduhelm, also known as aducanumab. ... Earlier this week, Joel S. Perlmutter, a neurologist at Washington University in St. Louis, resigned from the committee, according to the trade publications Stat News and the Pink Sheet. (McGinley, 6/9)
Axios:
Pharma Industry Insiders Disavow FDA's Approval Of Aduhelm
A new poll of more than 1,400 people who work in the biotech and pharmaceutical industries by John Carroll of Endpoints News reveals a clear consensus: The FDA made a big mistake approving Aduhelm, Biogen's Alzheimer's treatment, and the $56,000 price tag does not match any possible benefit. Even the industry's own experts are not defending the FDA and Biogen. (Herman, 6/10)
CNN:
New Alzheimer's Drug Aducanumab - Cost, Side Effects, Timeline And Other Questions Answered
Patients and their families are starting to inquire about the new Alzheimer's drug approved this week by the US Food and Drug Administration. Shipments of the medication are expected to go out in just a couple of weeks. Hospitals are on tap to administer treatment when needed. And there is serious division in the FDA, especially around the drug's effectiveness. (Howard, 6/9)
Cincinnati Enquirer:
UC Health To Offer Just-Approved Alzheimer's Disease Drug Aducanumab
UC Health will be among three sites in Ohio to administer the first medication to target an underlying cause of Alzheimer's disease and the first that's been approved for use in nearly two decades. The Food and Drug Administration approved aducanumab, produced by Biogen, Inc., and to be marketed under the name Aduhelm on Monday, and UC Health, announced its role in treatment ion Wednesday. The drug is expected to be available to patients later this year, officials said. Aducanumab is administered through monthly intravenous infusions at specialty infusion centers such as UC Health. (DeMio, 6/9)
