The US Food and Drug Administration approved today Monday the first new drug for Alzheimer's disease, a controversial decision, was made despite opposition from the agency's independent advisory committee and some Alzheimer's experts who said there was insufficient evidence that the drug could help patients.
From the NYT publication: The drug aducanumab, which will be marketed under the brand name Aduhelm, will be a monthly intravenous infusion designed to slow cognitive loss in people with mild memory and thinking problems.
It is the first approved treatment for Alzheimer's disease that does not simply treat the symptoms of dementia.
Recognizing that clinical trials of the drug provided incomplete evidence of its effectiveness, the FDA granted approval on the condition that the manufacturer, Biogen, conduct a new clinical trial.
During the years it may take for these tests to be completed, the drug will be available to patients, the FDA said.
If research does not prove that the drug is effective, the FDA may (but is not required to) revoke its approval.