Roche’s balovaptan has picked up a Breakthrough Therapy Designation in the US for its potential as a treatment for people with autism spectrum disorder (ASD), potentially placing the drug on a faster path to market.
Balovaptan, a vasopressin 1a (V1a) receptor antagonist previously known as RG7314, has shown potential in improving social interaction and communication in people with the condition, says Roche.
Clinical trial evidence implicates the V1a receptor in mediating and modulating key social behaviours - such as repetitive behaviours, restrictive interests and communication issues - that are challenging for individuals with ASD and for which no pharmacological treatments currently exist.
“We are very pleased that the FDA has granted Breakthrough Therapy Designation for balovaptan, in recognition of its early promise for individuals with ASD,” said Sandra Horning, Roche’s chief medical officer and head of Global Product Development.
“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.”
The World Health Organisation estimates that global prevalence of ASD is around one in every 160 people; in the EU, prevalence estimates range from 57 to 67 per 10,000 children.