The decision disregarded warnings from independent advisers that the much-debated treatment hasn't been shown to help slow the brain-destroying disease.
- In tonight's health watch, the FDA has just approved the first new drug for Alzheimer's disease in nearly 20 years. Some are hailing it a victory for people with the disease and their families, but critics question if there was enough evidence to approve the drug. CBS 4 Femi Redwood has the latest.
- This is a new type of treatment for Alzheimer's disease, Biogen's as you can imagine is given by infusion every four weeks and researchers say it targets the disease in a way that's never been done before. The Alzheimer's Association calls the FDA'S approval historic for patients and their families.
- It treats the underlying course of the disease. Amyloid is the sticky that clogs up the brain. By removing that, it is assumed that the individual will have clinical benefit and improvements in cognitive decline.
- Six million Americans are currently living with Alzheimer's disease in the US. Until now, other Alzheimer's drugs only manage symptoms.
- This treatment ushers in a new era in Alzheimer's treatments and we know that a first in class drug invigorates the treatment pipeline overall.
- The decision to approve the drug comes despite objections from the FDA'S independent panel of neurological experts. The Food and Drug Administration is not required to follow their advice. Dr. Caleb Alexander is an FDA advisor who recommended against the drug's approval.
- I think the jury is still out on whether it works, and there is a clear standard that manufacturers have to meet in order to gain market access. And in this instance, I think that the evidence is still quite murky as to the safety and especially the effectiveness of this product.
- The FDA is requiring the drug maker to conduct a follow up study to confirm benefits for patients. The FDA could pull the drug from the market if the study fails to show effectiveness. Femi Redwood, CBS News, New York.
- Some of the side effects of the drug include headaches, confusion, trouble walking, and falls. Dr. Alexander points out those are also symptoms of progressive Alzheimer's disease. So that could pose a challenge for doctors and caregivers to figure out if a patient is experiencing them from the drug or the disease.