In The Politics of Autism, I discuss the role of the Food and Drug Administration.
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.