On 8 October, Roche has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for gantenerumab, an anti-amyloid beta antibody developed for subcutaneous administration, for the treatment of Alzheimer's disease (AD). According to the FDA, the Breakthrough Therapy designation is a process designed to expedite the development of drugs that are intended to treat a serious condition. The benefits of a Breakthrough Therapy designation include more intensive guidance on an efficient development program as well as eligibility for rolling review and potentially priority review. The FDA's decision on gantenerumab 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.
Roche is evaluating gantenerumab in two ongoing parallel, global, placebo-controlled and randomised Phase III trials, named GRADUATE 1 and 2. Both trials are investigating the effect of gantenerumab on amyloid load and downstream biomarkers of disease progression as well as the safety and efficacy of gantenerumab in people with early AD. The studies include more than 2,000 participants in up to 350 study centers in more than 30 countries worldwide. Both trials are expected to be completed in the second half of 2022.
https://www.roche.com/investors/updates/inv-update-2021-10-08.htm
