Policy & Regulation
Genentech wins FDA's breakthrough therapy designation for gantenerumab for Alzheimer's Disease
11 October 2021 -

Biotechnology company Genentech reported on Friday the receipt of Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for anti-amyloid beta antibody for gantenerumab for subcutaneous administration in patients living with Alzheimer's disease (AD), a progressive, fatal disease of the brain characterized by a decline in memory, language, thinking skills, mood and behaviour.

The US FDA's designation is based on the company's data showing that gantenerumab significantly reduced brain amyloid plaque, a pathological hallmark of AD, in the ongoing SCarlet RoAD and Marguerite RoAD open-label extension trials, as well as other studies.

Gantenerumab reportedly lowered brain amyloid plaques in patients with sporadic AD in the SCarlet RoAD and Marguerite RoAD open-label extension studies and in patients with inherited AD in the DIAN-TU-001 study. The learnings from the company's studies have been incorporated into the optimized design of two ongoing parallel, global, placebo-controlled and randomized Phase III trials, GRADUATE 1 and 2.

According to the company, 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 (AD).