In a very controversial decision, the Food & Drug Administration, FDA, has approved a new drug to treat Alzheimer’s disease—the first new medication approved in almost two decades.  The move was hotly debated as some questioned the results of a clinical trial.  The agency’s independent advisory committee and some experts on dementia believe that there is not enough evidence that the drug is effective.  Aducanumab, which will be marketed under the brand name Aduhelm, is a monthly IV infusion meant to slow the onset of Alzheimer’s disease.  The FDA granted approval only on the condition that Biogen, the manufacturer, conduct a new clinical trial.  This will take seven years.  However, in the meantime those showing early signs of Alzheimer’s can opt in to the treatment.  “The data included in the applicant’s submission were highly complex and left residual uncertainties regarding clinical benefit,” the FDA’s director of the Center for Drug Evaluation and Research, Dr. Patrizia Cavazzoni, wrote on the agency’s website.  However, she stated that the agency decided to approve the drug through a program called “accelerated approval.”  Although it’s uncertain that the drug will work, many of those suffering from early-onset Alzheimer’s disease will likely be willing to take the risk.

https://www.forbes.com/sites/leahrosenbaum/2021/06/04/fdas-decision-on-biogen-alzheimers-drug-will-be-a-watershed-moment-for-the-agency—and-the-biotech-industry/?sh=26b742d2439a&utm_source=newsletter&utm_medium=email&utm_campaign=dailydozen&cdlcid=607e1442fe2c195e916f3bb4

https://www.nytimes.com/2021/06/07/health/fda-approves-alzheimers-drug.html

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