News Report | February 18, 2018
FDA Grants Breakthrough Therapy Status To Potential Autism Drug To Improve Social Interaction & Communication
On January 29, 2018, Roche announced that the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for balovaptan, Roche's investigational oral medicine to help improve core social interaction and communication in adults with autism. Balovaptan is a vasopressin 1a (V1a) receptor antagonist. The FDA’s decision was based on efficacy findings in the “Vasopressin ANtagonist to Improve sociaL communication in Autism” (VANILLA) study. The study was a Phase II trial of balovaptan in adults with autism. The FDA Breakthrough Therapy Designation is intended to expedite the development and review of medicines with early evidence of substantial potential . . .