Third FDA Panel Member Quits Over Approval of Alzheimer’s Drug
Aaron Kesselheim, director of Brigham and Women’s Hospital’s Program on Regulation, Therapeutics, and Law and who had served on the committee since 2015, said the FDA approval of Biogen’s Aduhelm “was probably the worst drug approval decision in recent U.S. history.”
Stat:
Third Member Of FDA Expert Committee Resigns Over Alzheimer's Decision
A third member of a Food and Drug Administration expert panel has resigned over the agency’s contentious approval of an Alzheimer’s therapy this week, a sign of a growing backlash over the decision. In a letter to acting FDA Commissioner Janet Woodcock on Thursday, Aaron Kesselheim, who had served on the FDA’s advisory committee for nervous system therapies since 2015, wrote that the approval of Biogen’s Aduhelm “was probably the worst drug approval decision in recent U.S. history.” (Joseph, 6/10)
Axios:
Biogen Says FDA Didn't Push For Trial Before Alzheimer's Approval
Two Biogen executives said in an interview the company's newly approved Alzheimer's drug is priced fairly, and that it didn't conduct another clinical trial before approval because the FDA didn't push them to do so. The scientific consensus is the drug, Aduhelm, has not been proven to work. But Biogen and the FDA are content with "hopefully" validating the $56,000 drug's efficacy at some unknown point in the future. (Herman, 6/11)
Stat:
Advocates Blast The FDA For Not Moving As Fast On ALS As On Alzheimer’s
The Food and Drug Administration fast-tracked Biogen’s divisive Alzheimer’s drug Aduhelm, but it’s not going to do the same for amyotrophic lateral sclerosis anytime soon — and ALS advocates are outraged. The FDA approved Aduhelm on Monday under “accelerated approval,” a special pathway that lets the agency greenlight drugs based on so-called surrogate endpoints. That means drug makers can prove that tumors shrank or plaques in the brain disappeared, rather than demonstrating that the drug helps cure or treat a disease itself. The pathway had until now been used almost exclusively for cancer drugs, but FDA’s drug center chief Patrizia Cavazzoni told reporters Monday that she hopes it will be used more frequently for neurodegenerative diseases. (Florko, 6/11)
Boston Globe:
What’s Next For The New Alzheimer’s Drug? Lots Of Thorny Issues Ahead
Despite all the excitement surrounding the FDA’s approval on Monday of a controversial treatment for Alzheimer’s disease, the drug won’t be flowing into a lot of patients’ arms anytime soon. Aduhelm, made by Cambridge-based Biogen, poses an array of thorny issues that have yet to be untangled, including how to provide the monthly hour-long infusions and whether insurers will pay for the drug despite the $56,000 annual price tag. And some consumers may face hefty out-of-pocket charges, which could make them think twice about taking a drug with known risks and uncertain benefits. (Freyer, 6/10)
ABC News:
Medicare Copays For New Alzheimer's Drug Could Reach $11,500
A new $56,000-a-year Alzheimer’s drug would raise Medicare premiums broadly, and some patients who are prescribed the medication could face copayments of about $11,500 annually, according to a research report published Wednesday. The drug, called Aduhelm, was approved by the Food and Drug Administration only this week. It's the first Alzheimer's medication in nearly 20 years, though it doesn't cure the life-sapping neurological condition. Some experts question whether Aduhelm provides any benefit to patients, but the FDA determined it can reduce harmful clumps of plaque in the brain, potentially slowing dementia. (Alonso-Zaldivar, 6/10)
Fierce Healthcare:
Top Dem Senator Calls Price Of Aducanumab 'Unconscionable'
A top senator criticized Biogen’s $56,000 price tag for a controversial new Alzheimer’s disease drug and revived calls for a bipartisan approach to fixing drug prices. Sen. Ron Wyden, D-Oregon, slammed the price for the drug aducanumab, which goes by the brand name Aduhelm and was approved by the Food and Drug Administration (FDA) earlier this week. The accelerated approval comes after FDA advisers questioned the effectiveness of the treatment. “There is little data showing it actually does what the company says it will do,” said Wyden during a Thursday hearing of the Senate Finance Committee. “Despite that, Aduhelm has an unconscionable list price of $56,000 per year.” (King, 6/10)
Also —
The Washington Examiner:
Scientists Discover Potentially Dangerous Metals In Brains Of Alzheimer's Patients
Scientists have discovered particles of copper and iron in the brains of deceased Alzheimer’s patients, a discovery that could lead to new treatments for the disease. In an article in the journal Science Advances, researchers from Keele University and the University of Warwick in the United Kingdom found traces of the elemental forms of copper and iron in amyloid plaque, proteins that form in the brains of Alzheimer’s patients. (Hogberg, 6/10)
KHN:
KHN’s ‘What The Health?’: Our 200th Episode!
The Food and Drug Administration found itself in the hot seat this week when it approved a controversial new drug to treat Alzheimer’s disease with scant evidence of its effectiveness. Meanwhile, as health policy watchers wait for the Supreme Court to rule in a case threatening the Affordable Care Act, the Biden administration is reporting that a record 31 million Americans have health insurance as a direct result of the health law. And President Joe Biden seeks to gain goodwill overseas as he announces the U.S. will provide 500 million doses of covid vaccine to aid international health efforts. (6/10)
