New Alzheimer Disease Drug to Be Submitted for FDA Approval

FDA Approves New Combination Alzheimer’s Drug
New analysis of study results suggests highest dose of aducanumab may help slow cognitive decline.

(HealthDay News) — A new drug to treat early Alzheimer disease will be submitted to the U.S. Food and Drug Administration for approval, maker Biogen Inc. said Tuesday.

Earlier this year, the company stopped two 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.

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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 two studies included more than 3,000 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 percent 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.

AP News Article

Biogen Press Release