Closeup of gloved hands preparing an infusion bottle

The pharmaceutical firm Biogen has stopped a real-world clinical trial for its federally approved Alzheimer’s disease drug aducanumab (Aduhelm).

Biogen said its decision was prompted by scant clinical use and limited national coverage for the drug, FiercePharma has reported. After a controversial approval by the Food and Drug Administration, Medicare chose to allow reimbursement for clinical trial participants only, due to remaining questions about the drug’s safety and efficacy. Aduhelm is a monoclonal antibody, delivered intravenously to target and break down Alzheimer’s brain plaques, with the goal of slowing cognitive decline.

Out of the 6,000 trial participants that Biogen had planned to recruit, only 29 had joined over a seven month period. On ClinicalTrials.gov., the drugmaker stated that the trial was now “not feasible for enrollment.”

Medicare’s April decision to only cover the drug for clinical trials prompted an outcry among patient advocates such as the Alzheimer’s Association. 

“People living with Alzheimer’s disease deserve the same access to therapies given to those living with other conditions like cancer, heart disease and HIV/AIDS,” it stated in January.

Proceed with caution

But CMS said that its coverage decision was based on peer-reviewed studies, plus invited input from 10,000 stakeholders. The “vast majority” of these respondents encouraged restricting use of the drug to controlled settings while more evidence is gathered about its safety and efficacy, CMS Administrator Chiquita Brooks-LaSure told The New York Times at the time.

Long-term care physicians, meanwhile, have cautioned against prescribing the drug for facility residents until more studies are completed, ideally including participants in that population.

More trials in the works

Biogen still has two other studies of Aduhelm’s efficacy in the works. These include the phase 4 ENVISION trial, conducted as a part of Aduhelm’s accelerated FDA approval. Another late-stage trial involves re-dosing earlier trial participants to determine the longer-term effects of the drug, according to FiercePharma.

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