The Food and Drug Administration of USA (Food and Drug Administration) approved today Monday the first new drug for the disease Alzheimer, a controversial decision that came despite opposition from the agency's independent advisory board 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 intended to slow cognitive loss in people with mild problems memory and thought.
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 insufficient evidence of its effectiveness, the FDA granted approval on the condition that the manufacturer company Biogen, will conduct a new clinical trials.
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.
