FDA Approves New Alzheimer's Drug
It's not like scientists haven't been working on novel chemical compounds for the past 20 years to treat Alzheimer's disease. Just that the illness has proven to be a challenging riddle to solve. Alzheimer's disease is the most prevalent form of dementia in elderly people, affecting six million Americans and 30 million people globally, although the U.S. has only licensed one medicine to treat the condition. For the past 20 years, individuals with Alzheimer's have only had five drugs to choose from.
However, drug producer Biogen has now developed aducanumab, the first Alzheimer's treatment that targets the illness' underlying causes rather than its symptoms. According to Biogen, aducanumab, whose commercial name will be Aduhelm, targets amyloid-forming proteins that aggregate to form cell-damaging plaques on Alzheimer's patients' brains. Many scientists think that the brain's amyloid plaque buildup makes it more difficult for brain cells to communicate with one another. The cells gradually die as a result of the inability to communicate, and patients' dementia symptoms get worse.
Through an expedited approval procedure, the FDA authorized the use of aducanumab for Alzheimer's on June 7, 2021. Patients will receive the medication as a monthly intravenous infusion, and according to Biogen, annual treatment costs will be staggering $56,000, not including the price of diagnostic exams and brain scans. But if it works, it's a tiny price to pay for the elimination of symptoms like forgetfulness, communication issues, and memory loss for those who can afford it. The FDA's decision, according to critics, indicates a lowering of standards in response to pressure from Alzheimer's advocacy groups, patients, and their families, and there is very little proof that aducanumab will be effective. Furthermore, it will be challenging to perform a post-market trial if the medication turns out to be largely useless because most patients who can obtain a medication from their doctor won't want to take a chance on receiving a placebo in a clinical experiment.
One of the FDA's most contentious decisions in recent years has been the approval of aducanumab. Doctors, researchers, advocates, and patients have strong disagreements regarding whether aducanumab appears to be more beneficial than a placebo in a 2019 drug trial. Due to the FDA advisory panel's choice to approve the medicine over the advice of medical professionals, two members of the panel resigned.
The Washington Post quoted Mayo Clinic physician David S. Knopman as saying that he didn't "want to be part of a fake process" that led to the drug's approval. Although I recognize that the committee is advisory, the Washington Post reports that he complained in his resignation letter to the FDA that "the whole drama of the approval of aducanumab... made a farce of the committee's consultation procedure.
A member of the FDA's expert panel for nervous system medicines and a neurologist, Joel S. Perlmutter of Washington University in St. Louis, also resigned in protest. Ten of the eleven members of the advisory group that met in November 2020 concluded that the study presented provided no support for the hypothesis that the medication would slow cognitive deterioration. Biogen asserts that further trials showed the medicine functioned significantly better in bigger doses for longer periods of time. As a result of "strong evidence that aducanumab lowers amyloid beta plaques in the brain," the FDA came to the conclusion that "it is reasonably likely to forecast major benefits for patients."