Roche's Gantenerumab Gets FDA Breakthrough Therapy Designation for Alzheimer's Disease

The U.S. Food and Drug Administration has granted breakthrough therapy designation to Roche Holding AG's gantenerumab for the treatment of people living with Alzheimer's disease.

The Swiss pharmaceutical major said Friday that the FDA's decision is based on data showing that gantenerumab, an antibody developed for subcutaneous administration, significantly reduced brain amyloid plaque, a pathological hallmark of Alzheimer's disease.