Regulators at the US Food and Drug Administration seem to have a favorable view of Biogen's Alzheimer's disease therapy, Stat News reports.
In early studies, aducanumab seemed to lead to a decline in the amount of amyloid protein that accumulates in Alzheimer's disease patients' brains as well as limit cognitive decline. But trial data led the company to conclude the drug was not working as hoped and it terminated its studies. However, in 2019, the company resurrected the drug, as Time magazine then reported. In particular, the Wall Street Journal reported that it appeared that patients with a certain ApoE variant given a high dose of the drug experienced less cognitive decline.
According to Stat News, FDA officials seem to support Biogen's assessment of its trial data that the drug is helpful to patients. "[T]he applicant has provided substantial evidence of effectiveness to support approval," the agency wrote in a recently released document.
Stat News adds that a panel of outside advisors to FDA are to meet Friday to discuss whether to recommend aducanumab for approval. CNBC adds that the agency's final decision on the drug is expected by March.