Roche wins FDA's breakthrough therapy label for autism drug

ZURICH: Swiss drugmaker Roche said on Monday the U.S. Food and Drug Administration granted its breakthrough therapy designation for Balovaptan to treat autism spectrum disorder (ASD), potentially accelerating its development and approval.

Balovaptan, which may improve social interaction and communication in people with ASD, is being developed by Roche’s Swiss-based pRED research unit and has an expected filing date of after 2020, according to the company’s website.

Autism spectrum disorder has no standard FDA-approved drugs for its core symptoms such as social interaction difficulties, communication challenges and a tendency to engage in repetitive behaviors. Roche said Balovaptan has shown the potential to improve social interaction and communication in people with ASD.

“We look forward to working closely with the FDA in the hope that we can bring this medicine to these individuals as quickly as possible,” said Roche Chief Medical Officer Sandra Horning.

Roche’s pRED research and development unit has historically lagged the output of its California-based Genentech unit, the source of nearly all its biggest sellers.

Still, the Basel-based company has begun highlighting several pRED medicines, including Balovaptan, as among its top drug prospects.