Biogen Alzheimer’s Drug Approval Prompts FDA Expert To Resign
An agency advisory committee recommended against the Food and Drug Administration approving Aduhelm, and one of its expert members has since resigned. More controversy about the drug's approval is reported in CNBC, Stat, Axios, The Baltimore Sun and Fox News.
Stat:
Member Of FDA’s Expert Panel Resigns Over Alzheimer’s Therapy Approval
Following the Food and Drug Administration’s polarizing authorization of the Alzheimer’s therapy Aduhelm on Monday, a member of an agency advisory committee that recommended against the drug’s approval has resigned. Neurologist Joel Perlmutter of Washington University in St. Louis, a member of the FDA’s expert panel for nervous system therapies, told STAT in an email that he had quit the committee on Monday “due to this ruling by the FDA without further discussion with our advisory committee.” (Joseph, 6/8)
CNBC:
Biogen Faces Tough Questions On $56K-A-Year Price Of New Alzheimer's Drug
Biogen on Tuesday faced tough questions from Wall Street analysts over the $56,000 annual cost of its newly approved Alzheimer’s drug, Aduhelm – a price tag executives are calling “fair” and “responsible.” Shares of Biogen surged 38% on Monday after the FDA announced it approved the company’s drug, scientifically known as aducanumab. It is the first medication cleared by U.S. regulators to slow cognitive decline in people living with Alzheimer’s and the first new medicine for the disease in nearly two decades. (Lovelace Jr., 6/8)
Stat:
Biogen Isn’t Worried About Backlash To Price Of Alzheimer’s Drug
Amid a firestorm of controversy around its decision to charge $56,000 a year for an Alzheimer’s disease treatment whose benefits are disputed, Biogen defended its decision on Tuesday, pointing to lifesaving cancer therapies that can cost nearly three times as much. “We believe the price is substantiated by the value it is expected to bring to patients, caregivers, and society,” CEO Michel Vounatsos said on a triumphant conference call with Wall Street analysts. (Garde, 6/8)
Stat:
Biogen, FDA At Odds Over Timing Of Confirmatory Trial Of Alzheimer’s Drug
Biogen and the Food and Drug Administration are at odds over the timing of a confirmatory trial for the company’s newly approved drug for Alzheimer’s disease, an issue of critical importance in determining whether the medicine is delivering benefits to patients. Hours after the approval of Aduhelm on Monday, Biogen CEO Michel Vounatsos said that the company could take up to nine years to satisfy the FDA’s post-approval requirement that it conduct an entirely new clinical trial to confirm the benefit of the drug for patients with Alzheimer’s. Those remarks, made during an interview with CNBC, were not received well inside the agency because they suggested Biogen felt no urgency to complete the study in a timely manner, an FDA official said. (Feuerstein and Herper, 6/8)
Also —
Axios:
New Alzheimer's Drug Could Blow Up Health Care Spending
Biogen's new Alzheimer's treatment could be experts' nightmare drug spending scenario: An extremely expensive product that millions of desperate patients could be eligible for — and it may not even work. Alzheimer's is a devastatingly common disease with no cure. But the FDA's decision this week paved the way for a free-for-all in which taxpayers foot most of the enormous bill for a drug that hasn't been proven effective. (Owens, 6/9)
The Baltimore Sun:
There’s A New Alzheimer’s Drug, So What’s The Problem? A Johns Hopkins Doctor Explains
After years of disappointing studies of potential treatments for the more than 6 million people living with Alzheimer’s disease, the U.S. Food and Drug Administration approved a new drug Monday called aducanumab that is sure to garner significant interest. The drug, however, followed an unusual regulatory path and did not convince a key advisory panel that it works. (Cohn, 6/9)
Fox News:
Who Should Take New Alzheimer's Drug? Expert Weighs In
After the Food and Drug Administration granted approval to the first Alzheimer’s drug in nearly two decades, Biogen's Aduhelm (aducanumab), doctors are left triaging patient calls in a bid to find the appropriate patient with a mild, early course of disease. Dr. Douglas Scharre, a neurologist and director of the division of Cognitive Neurology at Ohio State Wexner Medical Center, and clinical investigator on Biogen’s studies, explains the antibody treatment works by clearing toxic amyloid proteins from brain tissue, though patients with late stage Alzheimer’s disease are unlikely to benefit. However the FDA issued a broad indication for approval. (Rivas, 6/8)
