First FDA Approved Alzheimer Drug In 20 Years, Aducanumab Or Aduhelm, By Biogen Inc.
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US government health officials have approved the first new drug for Alzheimer’s disease in nearly twenty years. Regulators say the drug, which will be known as Aduhelm, is the first treatment that targets the causes of the disease, rather than its symptoms. But the approval is controversial – with some experts saying there’s not enough firm evidence of real benefits, in the video published on June 7, 2021, “FDA approves controversial Biogen Alzheimer’s drug | DW News“, below:
Note: In New York Times, it is reported that three scientists have resigned from the independent committee that advised the agency on the treatment. Among these three scientists, Harvard Professor of Medicine Dr. Aaron Kesselheim, after being on the committee for six years, said, “This might be the worst approval decision that the FDA has made that I can remember.” He added, “there’s no good evidence that the drug works.” The other two resigned members of the committee, expressing dismay at the approval of this drug despite committee’s overwhelming rejection of it after reviewing clinical trial data in November.
The FDA has approved a drug for people with Alzheimer’s disease. Dr. Tara Narula explains how it could make a difference for those diagnosed with the disease and why some experts are skeptical about the evidence that led to approval, in the video published on June 8, 2021, “FDA approves first new Alzheimer’s drug in nearly two decades, raising hopes despite skepticism“, below:
The first new treatment for Alzheimer’s disease for nearly 20 years has been approved by regulators in the United States, paving the way for its use in the UK, in the video published on June 7, 2021, “US approves first new Alzheimer’s drug in 20 years – BBC News“, below:
This newly approved Alzheimer drug, Aducanumab, aka Aduhelm:
- clears plaque buildup in the brain
- can cause swelling in the brain for some
- approved on an accelerated pathway
To better understand this newly approved drug by FDA for Alzheimer, Aducanumab, please refer to the excerpt from wikipedia, in italics, below:
Aducanumab, sold under the brand name Aduhelm, is used to treat Alzheimer’s disease (AD). It is an amyloid beta-directed monoclonal antibody.
Aducanumab targets aggregated forms of β-amyloid found in the brains of people with Alzheimer’s disease, in the hopes of reducing its buildup.
Aducanumab was approved for medical use in the United States in June 2021, and it represents a first-of-its-kind treatment approved for Alzheimer’s disease. It is the first new treatment approved for Alzheimer’s since 2003, and is the first therapy that targets the fundamental pathophysiology of the disease. Aducanumab’s approval was controversial due to ambiguous clinical trial results surrounding its efficacy. The drug was approved under the FDA’s accelerated approval pathway, and the FDA required a follow-up study within the next 9 years to see if the drug helps treat symptoms of Alzheimer’s
Aducanumab is indicated for the treatment of Alzheimer’s disease. However, “the basis of approval was a surrogate endpoint that has not been shown to correlate with any clinically meaningful outcome for patients”.
Aducanumab was developed by Biogen Inc., which licensed the drug candidate from Neurimmune, its discoverer. Biogen halted development of the drug in March 2019, after preliminary data from two phase III trials suggested it would not meet the primary endpoint.
Researchers evaluated the efficacy of aducanumab in three separate studies representing a total of 3,482 participants. The studies consisted of double-blind, randomized, placebo-controlled dose-ranging studies in participants with Alzheimer’s disease. Participants receiving the treatment had significant dose-and time-dependent reduction of amyloid beta plaque, while participants in the control arm of the studies had no reduction of amyloid beta plaque.
Drug treatment is estimated to cost US$56,000 per year, and Biogen’s CEO stated that they would maintain this price for at least four years. For patients with applicable health insurance and/or Medicare, the copayment for such therapy would be about $11,500 annually. Additional costs include charges for the one hour infusion every 4 weeks. Because of drug adverse reaction risks, patients have to undergo regular brain monitoring through expensive PET scans and MRI tests.
In November 2020, a panel of outside experts for the U.S. Food and Drug Administration (FDA) concluded that a pivotal study of aducanumab failed to show “strong evidence” that the drug worked and suggested that the FDA not approve aducanumab, citing questionable efficacy and multiple “red flags” found with the data analysis. The final decision of the FDA to green-light the drug was made on June 7, 2021. The drug was considered controversial as clinical trials gave conflicting results on its effectiveness. Three members of the FDA review panel resigned after FDA approval for the drug. Public Citizen  and the Institute for Clinical and Economic Review criticized the approval. Patient advocacy groups lobbied heavily for the approval of the drug because of its novel status for a debilitating condition with very few therapy choices. Advocacy groups such as Alzheimer’s Association,  Alzheimer Society of Canada, and Alzheimer’s Foundation of America  were also in favor of the decision.
Mizuho Securities Senior Biotech Analyst Salim Syed joins Yahoo Finance Akiko Fujita to discuss the FDA approving Biogen’s Alzheimer’s drug, in the video published on June 8, 2021, “Biogen Alzheimer’s Drug: Doctors ‘won’t come out of the gates prescribing’ this: Analyst“, below:
The Food and Drug Administration on Monday approved Biogen’s Alzheimer’s disease drug aducanumab, making it 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. The Massachusetts-based biotechnology company said Monday that aducanumab’s list price is $56,000 per year; $4,312 per infusion. Kevin Huang, senior equity analyst covering biotech and medtech at CFRA, joined “Squawk Box” on Tuesday to discuss, in the video published on June 8, 2021, “Why this analyst remains a ‘skeptic’ on Biogen’s new Alzheimer’s drug“, below:
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