The agency’s Fast Track program is intended to expedite the development and review of new drugs that can treat serious or life-threatening illnesses and address unmet medical needs, according to the FDA’s website.
The progression of Alzheimer’s disease is linked to an accumulation of amyloid plaque in the brain. In a recent clinical trial, 165 patients received monthly treatments of aducanumab or a placebo for one year. Researchers found the drug not only destroyed the brain plaque, but also slowed cognitive decline.
Phase III trials for aducanumab are underway to determine the effectiveness of the treatment in large populations. Researchers expect trial results in about three years.
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