From RT.com….
The US Food and Drug Administration has scaled back the prescribed uses for a new Alzheimer’s drug, now limiting it to “mild” dementia cases, after several health advisers resigned in protest over a rushed approval process.
Drug developer Biogen announced the new prescribing label on Thursday, noting that aducanumab – also known by its trade name, Aduhelm – should be given only to those in the early stages of Alzheimer’s.
“Treatment with Aduhelm should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials,” the company said in a press release.
Though the FDA’s initial approval last month made no distinction between varying levels of disease, Biogen said that it has “no safety or effectiveness data” for other stages of the illness. The company’s head of R&D Alfred Sandrock added: “we submitted this label update with the goal to further clarify the patient population that was studied across the three Aduhelm clinical trials.”
