New Alzheimer's Drug to be Submitted for FDA Approval

New Alzheimer's Drug to be Submitted for FDA Approval

A new drug to treat early Alzheimer's 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.

A new analysis of more results suggests that the highest dose of aducanumab - which is meant to help the body clear harmful plaques from the brain - helped slow declines in thinking 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's 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 didn't provide details on what that might mean for patients.

"It's a tricky question" whether the study results are truly meaningful for patients until more details are known, Dr. Ronald Petersen, a Mayo Clinic dementia specialist who has consulted for Biogen on the studies, told the AP.

"We're really encouraged by the information that they've provided today," which shows the largest benefit so far for any experimental medicine, Rebecca Edelmayer, a scientist at the Alzheimer's Association, told the AP.

The group was not involved in the studies.

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