July 8 (Reuters) – Biogen Inc said on Thursday the U.S. Food and Drug Administration has approved changes to product information on its Alzheimer’s disease drug, effectively narrowing the target population, sending its shares down 3% before the bell.
Aduhelm, also known as aducanumab, was studied in patients with early disease who tested positive for a component of amyloid brain plaques, but the FDA approval last month did not restrict its use to a specific group of patients.
Treatment with the drug should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, according to the updated product information on the drug.
The updated label, which was approved by the FDA after the company submitted it, also said there was no safety or effectiveness data on initiating treatment at earlier or later stages of the disease.
The drug, which targets an underlying cause of the disease, was approved despite controversy over whether the clinical evidence proves the drug works.
