(WHTM) — On Monday, June 8, the FDA approved the first Alzheimer’s drug in nearly 20 years disregarding the warning from independent advisers that the treatment has not actually been shown to help slow the disease.
The drug developed by Biogen was approved and it is the only drug that U.S. regulators have stated can likely treat the underlying disease.
The Alzheimer’s Association responded to FDA’s announcement. According to the association, it is not a cure but it is a step in the right direction.
Aduhelm is a monthly injection meant for patients in the early stages of Alzheimer’s. The association says the cost and access to the drug is the next big question.
“What the announcement yesterday means is that becomes the association’s number one priority, eliminating barriers to access this and not only the medication but any diagnostic tests needed during treatment,” Clay Jacobs, executive director for the greater Pennsylvania chapter of the Alzheimer’s Association.
The FDA says Biogen has to conduct an additional clinical trial while the drug is in use. The trial will test to see how prevalent brain bleeding and swelling it and if those risks outweigh the drug effectiveness. If they do, approval could be rescinded.