FDA Approves First Alzheimer’s Drug In Nearly 20 Years Despite Efficacy Concerns
Summary from the AllSides News Team
The Food and Drug Administration on Monday approved a drug to treat patients with Alzheimer’s disease for the first time since 2003. Some experts have voiced concerns over conflicting evidence of the drug’s effectiveness, which prompted the FDA’s independent advisory committee to oppose approval in November 2020. Biogen, the drug’s developer, will be required to conduct a post-approval confirmatory trial to verify the drug's cognitive benefits. The drug, named aducanumab and branded Aduhelm, could be pulled from the market if no benefits are found.
Coverage was more widespread in center- and left-rated outlets as of Monday afternoon. Some coverage from across the spectrum focused on the efficacy debate, with other coverage focusing on the 20-year gap.
Featured Coverage of this Story
From the Left
F.D.A. Approves Alzheimer’s Drug Despite Fierce Debate Over Whether It Works
The Food and Drug Administration on Monday approved the first new medication for Alzheimer’s disease in nearly two decades, a contentious decision, made despite opposition from the agency’s independent advisory committee and some Alzheimer’s experts who said there was not enough evidence that the drug can help patients.
The drug, aducanumab, which will go by the brand name Aduhelm, is a monthly intravenous infusion intended to slow cognitive decline in people, with mild memory and thinking problems. It is the first approved treatment to attack the disease process of Alzheimer’s instead of just...
From the Right
FDA approves Biogen’s Alzheimer’s drug
The Food and Drug Administration (FDA) on Monday approved Biogen’s Alzheimer’s drug, marking the first new authorized therapy to treat the disease in nearly two decades. The drug, Aduhelm (aducanumab), had received mixed reviews following earlier clinical trials.
In a statement following the approval, Dr. Patrizia Cavazzoni, director of the FDA Center for Drug Evaluation and Research, said the agency used the Accelerated Approval pathway, which is when the FDA "approves a drug for a serious or life-threatening illness that may provide meaningful therapeutic benefit over existing treatments when the drug is...
From the Center
First New Alzheimer’s Drug in Nearly Two Decades Is Approved by FDA
The first drug promising to slow the memory-robbing march of Alzheimer’s disease was approved by U.S. health regulators, a watershed after years of research and billions of dollars in investment.
The U.S. Food and Drug Administration said it approved the drug, which has the molecular name aducanumab and will be sold as Aduhelm, based on evidence it reduces a sticky substance in the brain called amyloid that is associated with Alzheimer’s.
The drug’s sale offers hope to millions of people dealing with Alzheimer’s and their caregivers, given the lack of good options...
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