US FDA grants breakthrough therapy designation to Roche’s anti-amyloid beta antibody gantenerumab 

Gantenerumab is an investigational antibody in phase-III development for early Alzheimer's disease (AD)

The US Food and Drug Administration has granted breaktrough therapy designation to Roche’s gantenerumab, an anti-amyloid beta antibody developed for subcutaneous administration, for the treatment of people living with Alzheimer’s disease (AD), the company informed via a statement.

The statement further said that this designation is based on the data showing that gantenerumab significantly reduced brain amyloid plaque, a pathological hallmark of AD, in the ongoing SCarlet RoAD and Marguerite RoAD open-label extension trials, as well as other studies. Learnings from these studies have been incorporated into the optimised design of two ongoing parallel, global, placebo-controlled and randomised phase-III trials, Graduate 1 and 2. The pivotal trials are evaluating gantenerumab in more than 2,000 participants for more than two years and are expected to be completed in the second half of 2022.

“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, MD, PhD, Chief Medical Officer and Head, Global Product Development, Roche.

“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.”

The statement further informed that the breakthrough therapy designation is designed to accelerate the development and review of medicines intended to treat serious or life-threatening conditions with preliminary evidence that indicates they may demonstrate a substantial improvement over available therapies that have received full FDA approval. This designation for gantenerumab marks the 39th Breakthrough Therapy Designation for Roche’s portfolio of medicines.

Alzheimer's treatmentBreakthrough Therapy DesignationgantenerumabRocheUS FDA
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