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# Genentech ‘Breakthrough’ Status on Alzheimer’s Drug
- URL: https://www.fdaweb.com/genentech-breakthrough-status-on-alzheimers-drug/
- Published: 2021-10-08T12:00:00.000Z
- Updated: 2026-09-14T17:18:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150333

FDA has granted Genentech a breakthrough therapy designation for gantenerumab, an anti-amyloid beta antibody developed for subcutaneous administration in Alzheimer’s disease patients. According to the company, the designation is based on data showing that gantenerumab significantly reduced brain amyloid plaque in the ongoing SCarlet RoAD and Marguerite RoAD open-label extension trials, as well as other studies.

Knowledge and experience from the earlier studies have been incorporated into the “optimized design” of two ongoing parallel, global, placebo-controlled and randomized Phase 3 trials, GRADUATE 1 and 2, Genentech says. The trials are evaluating gantenerumab in more than 2,000 participants and its effect on amyloid load and downstream biomarkers of disease progression, as well as the safety and efficacy of gantenerumab in people with early Alzheimer’s. Data from both trials are expected in the second half of 2022.

Gantenerumab is an investigational IgG1 antibody designed to bind to aggregated forms of amyloid beta and remove brain amyloid plaques, a pathological hallmark of Alzheimer’s disease, the company says.