The food and drug administration approved the first new treatment for Alzheimer’s disease. This landmark decision has been in works for nearly 20 years and could help millions of Americans diagnosed with the condition.
The new medicine is called Aduhelm. This treatment, while it is not a cure, is pivotal and its progress in science is significant.
“On behalf of those impacted by Alzheimer’s and all other dementia, the Alzheimer’s Association welcomes and celebrates the historic FDA approval of aducanumab,” said Harry Johns, president and CEO of the Alzheimer’s Association. “This approval is a victory for people living with Alzheimer’s and their families.”
The FDA granted marketing clearance to the drug even though it was denied two years ago, but has shown it ability to clear toxic proteins.
Biogen, the company who makes the drug, said the yearly cost for a maintenance dose of Aduhelm, based on an average patient’s weight, would be $56,000.The out-of-pocket cost for patients with insurance will vary depending on their coverage. Analysts have expected it to cost between $10,000 and $25,000 per year, which would place it among the most expensive medicines marketed. The company expects to start shipping the drug in about two weeks.
The clinical trials showed the new drug has some negative side effects, including brain swelling and bleeding. People who want to use aduhelm will need to undergo brain scans to see if they are eligible for the treatment. About six million people in the United States have Alzheimer’s, and not all will qualify for treatment with the new drug.