Doctor, clinician wearing surgical gloves, readying an intravenous infusion

The Food and Drug Administration has provided a new label for the recently approved Alzheimer’s disease drug aducanumab (Aduhelm) that restricts its use to Alzheimer’s patients with mild cognitive impairment or mild dementia, drugmaker Biogen announced Thursday.

The drug was greenlit in June with no guidelines in place, as well as conflicting clinical trial data that may not be resolved until additional trials wrap up. By limiting Aduhelm’s use to people who fit the criteria for admission in original trials, the new label may answer some clinicians’ concerns about appropriate prescribing.

“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 new label language states. “There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.”

The drug, to be delivered via infusions, was not tested in populations that fit the health profile of people who reside in post-acute and long-term care facilities.

A “potentially dangerous and ineffective medication”

A major long-term care physicians advocacy group last week announced that it would not endorse prescribing the drug to residents in these settings. AMDA – The Society for Post-Acute and Long-Term Care Medicine, urged LTC clinicians to  “resist the urge to prescribe a potentially dangerous and ineffective medication that is untested in our population, even if it has FDA approval.”

The group said the drug lacks of evidence of benefit, has significant potential for dangerous side effects, requires sophisticated neuroimaging scans on follow-up, and costs too much.

Influential advocate the Alzheimer’s Association, a supporter of Aduhelm’s approval and use, has meanwhile praised the FDA’s new label change.

“We appreciate the FDA’s thoughtful consideration and response to the Alzheimer’s Association and others in the community including physicians, researchers and patients to ensure this treatment is prescribed only to those who may see benefit,” Maria C. Carrillo, Ph.D., Alzheimer’s Association chief science officer, said in a Thursday statement.

The label change is unlikely to affect the drug’s sales, Wall Street analysts told Reuters. The refined guidance will instead help the company secure reimbursement from insurance providers, who will want to know that the “right people” get the drug, one observer told the news outlet