July 8 (Reuters) - Biogen Inc said the U.S. drug regulator has narrowed the patient group that can use its Alzheimer’s disease drug, after the agency drew sharp criticism for approving the drug last month without proof of clear benefit against the disease.
Shares of the company fell nearly 3% before the bell on Thursday.
The U.S. Food and Drug Administration has been criticized for its decision to allow wide use of Biogen’s Aduhelm among patients even though the company had tested the drug only in patients with early disease who tested positive for a component of amyloid brain plaques.
Aduhelm, also known as aducanumab, was approved despite a lack of clear evidence showing the drug worked and against the advice of an outside group of advisers.
Several members of the FDA’s advisory panel have resigned in protest over the approval.
Biogen said it had asked for an update to the label, a written information that accompanies a drug, after “dialogue with FDA, physicians and patient advocates.” “The intent is to help prescribing physicians to engage with patients,” Biogen said in a statement.
The new label says that treatment with the drug should be initiated in patients with mild cognitive impairment or mild dementia stage of the disease.
It also says there is no safety or effectiveness data on initiating treatment at earlier or later stages of the disease.
The new patient population is largely in-line with how the drug was expected to be used, Truist Securities analyst Robyn Karnauskas said in a note. She expects roughly $12 billion in peak sales by 2031.
Biogen’s drug has been hailed by patient advocates and some neurologists eager for a treatment for the memory-robbing disease. Other doctors said clinical trial results were inconsistent and more proof was needed.