The Food and Drug Administration has granted Breakthrough Therapy designation to gantenerumab for the treatment of Alzheimer disease.
Gantenerumab is an investigational immunoglobulin G1 antibody designed to increase the clearance of soluble amyloid beta from the brain by binding to aggregated forms of amyloid beta.
The designation is based on data from the ongoing phase 3 SCarlet RoAD (ClinicalTrials.gov Identifier: NCT01224106) and open-label extension Marguerite RoAD (ClinicalTrials.gov Identifier: NCT02051608) trials, which evaluated the efficacy and safety of gantenerumab administered subcutaneously every 4 weeks in patients with prodromal and mild Alzheimer disease, respectively. Findings from both trials showed treatment with gantenerumab significantly reduced brain amyloid plaques in patients with sporadic Alzheimer disease.
The Company is also investigating the effect of gantenerumab on amyloid load and downstream biomarkers of disease progression, along with the efficacy and safety of gantenerumab in patients with early Alzheimer disease, in the pivotal phase 3 GRADUATE 1 (ClinicalTrials.gov Identifier: NCT03444870) and 2 (ClinicalTrials.gov Identifier: NCT03443973) trials. Data from both trials are expected in the second half of 2022.
“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,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development.
Ad hoc announcement pursuant to Art. 53 LR: Genentech’s anti-amyloid beta antibody gantenerumab granted FDA Breakthrough Therapy designation in Alzheimer’s disease. News release. Genentech. Accessed October 8, 2021. https://www.businesswire.com/news/home/20211008005371/en/Ad-hoc-announcement-pursuant-to-Art.-53-LR-Genentech%E2%80%99s-Anti-Amyloid-Beta-Antibody-Gantenerumab-Granted-FDA-Breakthrough-Therapy-Designation-in-Alzheimer%E2%80%99s-Disease.