Gantenerumab gets coveted BTD for Alzheimer's from FDA

Breakthrough Therapy designation (BTD) has been granted by the US Food and Drug Administration for gantenerumab in the treatment of people living with Alzheimer’s disease (AD), Genentech, the US biotech business of Swiss pharma giant Roche (ROG: SIX), revealed on Friday.

Roche's US traded shares increased 5.6% to $49.61 on the news.

This designation is based on 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. Learnings from these studies have been incorporated into the optimized design of two ongoing parallel, global, placebo-controlled and randomized Phase III trials, GRADUATE 1 and 2. The pivotal trials are evaluating gantenerumab in more than 2,000 participants for more than two years and are expected to be completed in the second half of 2022.