FDA Grants Breakthrough Therapy Designation to Gantenerumab

FDA Grants Breakthrough Therapy Designation to Gantenerumab

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FDA Grants Breakthrough Therapy Designation to Gantenerumab

The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy status to gantenerumab, a human antibody that’s expected to slow or even prevent cognitive decline and memory loss in Alzheimer’s disease. The FDA designation is intended to accelerate the development and review of candidate therapies with clinical evidence of substantial improvement over approved treatments for serious diseases. Gantenerumab, developed by Roche and its U.S. affiliate Genentech, is designed to bind and reduce amyloid-beta plaque formation in the…

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