Aduhelm (Aducanumab) and UsAgainstAlzheimer’s
Aducanumab is a treatment for early Alzheimer’s disease that is intended to slow the progression of the disease. It was approved by the Food and Drug Administration (FDA) in June, 2021, and is being marketed under the name Aduhelm. UsAgainstAlzheimer’s (UsA2) urged the FDA to approve aducanumab.
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"Biogen, Medicare, private insurers, and the FDA must immediately address patient concerns about affordability, equity, effectiveness, and whether [Aduhelm] is right for them. UsAgainstAlzheimer’s stands ready to help."
Read UsAgainstAlzheimer's full statement - New Alzheimer’s Treatment Must Be Affordable and Accessible; with Faster and More Inclusive Phase 4 Confirmatory Trial
UsAgainstAlzheimer’s Hails FDA Approval of Aducanumab, the First Disease-Modifying Therapy for Early-Stage Alzheimer’s
"We urge the FDA to approve aducanumab and put in place a platform to assess the real-world experience with the drug by persons in the early stages of Alzheimer’s disease." (Read the full letter UsA2 sent to the FDA.)
George Vradenburg and Russ Paulsen
Co-Founder and Chairman, UsAgainstAlzheimer's and Chief Operating Officer, UsAgainstAlzheimer's.
UsAgainstAlzheimer’s Survey Shows Alzheimer’s Patients Value a New Therapy that Slows Progression of Symptoms
“Alzheimer’s is a disease of greater prevalence and greater lethality than Covid-19. This is an ongoing pandemic. Its cost to America in terms of direct medical costs is significantly higher than cancer.” (Read the full article in Barron's.)
Co-Founder and Chairman, UsAgainstAlzheimer's
Op-Ed: Collaboration between the FDA and industry is essential to foster innovation in Alzheimer’s treatments
By George Vradenburg, Co-Founder and Chairman, UsAgainstAlzheimer's, and Dr. Jeffrey Cummings, Director, Chambers-Grundy Center for Transformative Neuroscience.
Aducanumab is an approved treatment for early Alzheimer’s disease that is intended to slow the progression of the disease. Aducanumab does this by promoting clearance of amyloid beta plaques, a hallmark of Alzheimer’s, from the brain. It has the potential to slow the rate of cognitive and functional decline in persons in the earlier stages of Alzheimer’s and may help preserve the cognitive abilities and functions of these patients for a longer time.
Aducanumab, which has been developed by Biogen, was approved in June, 2021 by the Food and Drug Administration. Now being marketed under the name Aduhelm, it is the first disease-modifying therapy approved for use in the U.S.
Aducanumab is approved for use by people living with early-stage Alzheimer’s disease and mild cognitive impairment, which are the groups in the clinical trials. The FDA approval calls for a post-marketing confirmatory study to see how the drug therapy works for different groups.
Aducanumab and UsAgainstAlzheimer’s
UsAgainstAlzheimer’s (UsA2) urged the U.S. Food and Drug Administration to approve aducanumab. By delaying the progression for people in the early stages of the disease, this drug therapy will give people more time to live independently and perform daily activities longer.
To people living with the disease and their caregivers, every single day matters. Approval of this drug is a powerful sign of hope for people living with Alzheimer’s after years of disappointment.
UsA2 also believes that FDA approval of aducanumab would have a ripple effect on pharmaceutical innovation that could spark additional investment by other companies in disease-modifying treatments and therapies.
Following FDA approval of the drug, UsAgainstAlzheimer’s has pushed for additional steps to make Aduhelm affordable and accessible for anyone who needs it and has supported Medicare coverage for the treatment, which has a list price of $56,000 a year. UsAgainstAlzheimer’s also has called on Biogen to include many more Black Americans and Latinos in the post-approval confirmatory study, and to complete that Phase 4 clinical trial faster than the nine years allowed by the FDA.
Statements by UsAgainstAlzheimer’s to FDA Advisory Committee: