FDA Approves First New Alzheimer’s Drug In 18 Years

A close up of some blue and yellow cells


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.â€Â  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

New Hope For Those With Alzheimer’s Disease

A purple square with the words " the end of alzheimer 's starts with me ".


The U.S. Food and Drug Administration (FDA) is set to rule soon on whether a promising drug by Biogen called aducanumab can be prescribed from those suffering from Alzheimer’s disease.  Although it has already been recommended by an FDA advisory panel of medical experts that the drug not be approved as two clinical trials had completely different results, Bloomberg Businessweek interviewed a man, Jeffrey Borghoff age 57, who was diagnosed with early-stage Alzheimer’s disease at 51.  He gave cudos to the drug, which he has been taking for years as part of an experimental drug trial.  :We’re fighting like hell to get this drug approved,†Borghoff told a reporter.  “Every day they are making progress in cancer and diabetes and other diseases.  We need something for Alzheimer’s disease,†he said.  Fingers crossed that the FDA approves the drug—they have until June 7 to make a decision.

Monterey, CA New Hope For Alzheimer’s Drug

A woman looking out of the window at her home.


The Food & Drug Administration FDA is taking another look at aducanumab, a potential new drug for treating Alzheimer’s Disease and dementia.  The drug candidate will undergo an additional three months of review after a panel of experts in November recommended against approving the drug.  Biogen and Eisai partnered on the development of the drug and delivered new data to the FDA, triggering the prolonged review time.  An independent committee of experts had criticism of both the drug’s merits and the interpretation of data by FDA scientists.  Biogen said the data from one clinical trial showed a slowing in cognitive decline compared to study participants who received a placebo.  In the second clinical trial, the drug failed to show a benefit.  However, Biogen says it is likely because fewer patients received the higher dosage.  Regular readers of my blog know that both my father and grandmother had this terrible disease when they passed away.  There are great people at our local chapter of Alzheimer’s Association in Ryan’s Ranch.  They also have a 24-hour hotline if you need support at 800-272-3900.

https://www.wsj.com/articles/fda-extends-review-of-biogen-eisais-alzheimers-drug-11611935425