HealthDay News — A new drug to treat early Alzheimer disease will be submitted to the US Food and Drug Administration for approval, maker Biogen Inc. said Tuesday.
Earlier this year, the company stopped 2 studies of the drug, called aducanumab, when initial results suggested it would not be effective, so the announcement about seeking approval for the drug is a surprise, according to the Associated Press.
A new analysis of more results suggests that the highest dose of aducanumab — which is meant to reduce amyloid plaque burden — helped slow declines in cognitive skills, said Massachusetts-based Biogen, which is developing the drug with Japan-based Eisai Co. Ltd.
The 2 studies included more than 3000 patients with mild cognitive impairment or early dementia due to Alzheimer disease. In one study, patients who received a high dose of the drug — given as monthly infusions — had 23% less decline on one measure of thinking skills and smaller declines on other measures, the AP reported. However, Biogen did not provide details on what that might mean for patients.