The FDA now says the drug should only be for people with mild illnesses -- only those patients who have been tested. Less than five weeks after the controversial Ohlem Alzheimer's drug was licensed, the Food and Drug Administration is recommending who should receive the drug, and Alzheimer's is limited to people with mild forms of the disease.
The FDA's general recommendation has been a controversial aspect of drug approval because it hasn't been confirmed by any information. The developer of Aduhelm Biogen has included only mildly ill people in clinical trials. Many critics of the approval immediately raised questions about why the drug was open to all.
But these critics - including researchers and industry experts - have been more inclined to confirm their outrage, as clinical trials have not convincingly shown that the drug works in the treatment of mild Alzheimer's disease. In fact, Biogen halted two similar Phase 3 trials in 2019, after Adolm canceled a "non-viability analysis". In only one of the abandoned trials, did the drug show a slight improvement in cognitive tests compared to the placebo group. Obviously, participants in another similar trial did not see any benefit. However, Biogen has submitted an interim analysis of the missing tests to the FDA. The agency's statisticians completely rejected Biogen's claim of efficacy, and the IAEA's Board of Independent Expert Advisors overwhelmingly endorsed it (10 out of 11 against, one vote "inconclusive").
However, the US Food and Drug Administration announced Adolham's approval on June 7. Although IAEA officials acknowledged at the time that the drug's "clinical benefit is uncertain," they approved it on the basis of an "alternative end point." This means that the FDA approval is not based on efficacy but rather on data that the drug appears to be able to remove beta-amyloid plaques from the brains of some Alzheimer's patients.Advertising
Although plaques have been linked to Alzheimer's disease, it is not clear if they are the root cause of the disease, and there are benefits to removing them. Other experimental Alzheimer's drug trials have found no link between plaque removal and cognitive improvement.
Critics quickly called the clip "disgraceful" and "dangerous". Three members of the agency's advisory board called for the removal of three senior Food and Drug Administration officials in protest of the resignation of Public Citizen Watch. Adding fuel to the fiery criticism of Biogen's decision to price Adolm for $56,000 a year. One analysis estimates that if the 5.8 million adults eligible for Medicare in an Alzheimer's country start taking Aduhelm, it could cost the federal insurance program $334.5 billion annually. In 2019, Medicare spent a total of $37 billion on all drugs in the same class as Aduhelm, a prescription drug. The striking cost estimates do not include the additional cost of brain scanning and safety monitoring required by the drug. While the effect of Adolem is not clear, known side effects of the drug include brain swelling and serious bleeding.
FDA updates to reduce patient potential to reduce cost estimates. But it may not be many. A recent study by Boston University researchers estimated that half of people with Alzheimer's disease could be classified as having mild disease. And even if 500,000 Medicare beneficiaries eventually use up Aduhelm, it could cost the federal government $29 billion annually.
This hard-to-obtain update after initial approval raises additional questions about how the FDA made its decision on Aduhelm. Currently, sensors Bill Cassidy, Dr. (R-La.) and Elizabeth Warren (D-Mass.) have called for this drug to be treated. The House Oversight and Reform Committee launched an investigation into its approval and pricing.
In a statement Thursday, Biogen's director of research and development, Alfred Sandrock Jr., said the FDA update "is based on our ongoing conversations with prescribers, FDA and patient advocates," and "most Patients “explain what has been studied.”
Amid a storm of criticism, the US Food and Drug Administration has restricted use of the Alzheimer's drug to $56,0006000
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