Controversial Alzheimer's Drug Withdrawn from Market Amid Concerns

Post by: Dr. Amrinder Pal Singh

_{(John Tlumacki/The Boston Globe/Getty Images)}

Biogen, the pharmaceutical company behind the controversial Alzheimer's drug Aduhelm, has officially pulled the drug from the market. Marketed as the first-ever treatment for cognitive decline associated with Alzheimer's, Aduhelm faced scrutiny since its accelerated approval by the US Food and Drug Administration (FDA) in June 2021. This decision was contentious, as it went against the advice of independent advisors who deemed the evidence of its benefits insufficient.

Following the FDA approval, at least three members of the 11-member independent committee resigned, highlighting the controversy surrounding Aduhelm. Congressional investigators criticized the accelerated approval process, describing it as "rife with irregularities." The FDA's decision to approve Aduhelm under the accelerated pathway, after initially considering it under the traditional approval pathway, raised concerns about the agency's interactions with Biogen, the lack of proper documentation, and inappropriate collaboration on a joint briefing document.

Biogen has stated that it is discontinuing Aduhelm to allocate more resources to Leqembi, a newer Alzheimer's medicine that received full approval through the traditional regulatory pathway in the previous year. Christopher Viehbacher, President and CEO of Biogen, emphasized Aduhelm as a groundbreaking discovery that paved the way for a new class of drugs and reinvigorated investments in the field.

Aduhelm, a monoclonal antibody targeting the build-up of amyloid beta protein in the brain, underwent two late-stage human trials. While it demonstrated a reduction in cognitive decline in one study, the results were not consistent across both trials. The drug's pricing also came under scrutiny, with a congressional report pointing to an "unjustifiably high price" of $56,000 per year for patients.

Leqembi, co-manufactured by Biogen and Eisai of Japan, is now the only FDA-approved treatment for Alzheimer's in the United States. Similar to Aduhelm, it targets amyloid beta and has shown modest success in reducing cognitive decline in patients with early-stage disease. Another potential contender, Eli Lilly's Donanemab, is awaiting approval after demonstrating similar efficacy in clinical trials.

Alzheimer's disease, the most common form of dementia, affects more than one in nine people over the age of 65. It is a progressive condition that worsens over time, impacting memory and independence. The withdrawal of Aduhelm from the market underscores the challenges and controversies in developing effective treatments for this devastating brain disorder.

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