Roche Receives Breakthrough Therapy for Alzheimer’s Disease
FDA based its decision on recent data from the ongoing SCarlet RoAD and Marguerite RoAD trials, which showed that Roche’s drug reduced a pathological hallmark of Alzheimer’s disease.
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By - FDA recently granted Roche’s anti-amyloid beta antibody, gantenerumab, breakthrough therapy designation to treat individuals living with Alzheimer’s disease.
The agency based its decision on recent data from the ongoing SCarlet RoAD and Marguerite RoAD trials, which showed that gantenerumab significantly reduced brain amyloid plaque, a pathological hallmark of Alzheimer’s disease.
Researchers are incorporating data from the trials into the optimized design of two global, placebo-controlled, and randomized Phase 3 trials, GRADUATE 1 and 2. In the trials, researchers are evaluating gantenerumab in over 2,000 participants.
Roche expects GRADUATE 1 and 2 to complete 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,” Levi Garraway, MD, PhD, chief medical officer and head of global product development of Roche, said in the announcement.
“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,” Garraway continued.
Gantenerumab is an investigational IgG1 antibody designed to bind to aggregated forms of beta-amyloid and remove brain amyloid plaques.
Roche will continue to explore various approaches and molecules to address key pathways of Alzheimer’s disease, including beta-amyloid, tau, and other innovative tools.
Alzheimer’s disease is the most common form of dementia that affects more than 55 million people worldwide and will reach 78 million people by 2030. The disease will cost the global economy $2.8 trillion per year by 2030.
In June 2021, FDA officially approved Biogen’s drug for Alzheimer’s disease, Aduhelm. This approval marks the first Alzheimer’s drug approval in nearly 20 years and the first to address cognitive decline in those with the illness.
The approval came after long speculation about the drug’s efficacy. Biogen pulled Aduhelm in 2019 after some trials showed it may not have much effect but ultimately reversed course and announced it would submit Aduhelm for approval after all.
