Approval for Aducanumab came just months after a scathing assessment by a panel of outside neurological experts voted "no" to a series of questions on whether the drug was effective. The FDA review of the drug has become a flashpoint in longstanding debates over the standards used to evaluate therapies for hard to treat conditions. On one side, Alzheimer's patients and their families are willing to try anything, even if it has a small benefit. On the other side, many experts warn that greenlighting the drug could set a dangerous precedent, approving a drug that is proven to have questionable benefits.
Aducanumab is the first new drug for Alzheimer's in almost 20 years. The new drug was developed by Biogen and Japan's Eisal Company. The drug did not reverse mental decline, only slowing it in one study. The drug will be given as an infusion every four weeks. "The FDA gets the respect that it does because it has regulatory standards that are based on firm evidence. In this case, I think they gave the product a pass," said Alexander, a researcher at Johns Hopkins University.
Many questions regarding the drug remain unanswered. How long do patients benefit? How do physicians determine when to discontinue the drug? Does the drug benefit more advanced dementia? The drug will likely be covered by virtually all insurers, including Medicare. Time will tell whether the drug will warrant the high price tag it will cost.
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