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

By Mauro Orru

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.

The designation aims to accelerate the development and review of medicines to treat serious or life-threatening conditions.

"For more than a decade, we've been committed to advancing the science of Alzheimer's as well as our investigational medicine gantenerumab, and we look forward to delivering a comprehensive and robust data set that furthers our collective understanding of this devastating disease," said Levi Garraway, Roche's chief medical officer and head of global product development.

"This Breakthrough Therapy Designation reinforces our confidence in gantenerumab, which would be the first subcutaneous medicine for the treatment of Alzheimer's disease with the potential for at-home administration," Mr. Garraway said.

Gantenerumab is in Phase 3 development, with trials assessing the antibody in more than 2,000 participants for more than two years that are expected to be completed in the second half of next year.

Write to Mauro Orru at [e-mail]; @MauroOrru94

(END) Dow Jones Newswires

October 08, 2021 12:16 ET (16:16 GMT)

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