Gantenerumab receives breakthrough therapy designation as Alzheimer’s treatment

The FDA has granted breakthrough therapy designation to gantenerumab, an anti-amyloid beta antibody developed for subcutaneous administration, as an Alzheimer’s disease treatment.

The administration based its designation decision on data that showed a significant reduction in brain amyloid plaque associated with gantenerumab (Roche/Genentech) use. The findings came as part of the ongoing Scarlet RoAD and Marguerite RoAD open-label extension trials, as well as from other studies.

Results of these studies have been used to inform the optimized design of two ongoing, parallel, global, placebo-controlled and randomized phase 3 trials, known as GRADUATE 1 and 2. The trials are investigating gantenerumab among more than 2,000 individuals for more than 2 years, with completion expected during 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,” Levi Garraway, MD, PhD, chief medical officer and head of global product development for Roche and Genentech, said in a press release. “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.”