The US Food and Drug Administration (FDA) has given approval for an updated label for the controversial Alzheimer′s drug aducanumab. It has stated that the drug should only be prescribed in patients with the earliest stages of disease.

The agency had approved the drug in early June amid controversy and had disregarded its own advisory panel’s recommendation not to approve it. The original prescribing information stated that the drug could be used for treatment of any patient with Alzheimer′s disease. However, the updated label now mentions that it should be given only in patients with mild cognitive impairment (MCI) or mild dementia stage of the disease. This is the patient population in which the treatment was initiated in the clinical trials leading to its approval… (Medscape)