The FDA Has Announced That Roche’s New Autism Drug Could Be A Breakthrough in The Treatment of Autism!
Roche’s new experimental drug has been awarded with ‘Breakthrough Therapy Designation’ by the United States Food and Drug Administration. The FDA announced the breakthrough designation for Roche’s new autism drug, Balovaptan. Balovaptan, which is a vasopressin 1a receptor antagonist, has shown promising results to improve the social interaction and communication of people with autism spectrum disorder. Roche said that Balovaptan had shown promising results in both animal and human clinical trials.
The FDA’s Breakthrough Therapy Designation for Balovaptan was based on efficacy findings in the VANILLA (Vasopressin ANtagonist to Improve sociaL communication in Autism) study, a Phase II trial of Balovaptan conducted on adults with autism spectrum disorder. There is currently a trial still being undertaken on children and adolescents with autism spectrum disorder. Roche has also announced that they have plans to undertake more trials using Balovaptan in the future.
Autism spectrum disorder, or ASD, is a developmental condition which affects how people interact, communicate, and behave with other people. It is a lifelong condition which places a large amount of stress and hardship onto families and those with ASD. Autism spectrum disorder is referred to as a spectrum disorder because of the large and diverse range of different symptoms and their severity. At the time of writing, there are no drugs or treatments available which “help improve the challenges that individuals may experience with social skills, repetitive behaviors, restrictive interests and communication,” Roche said. These core symptoms of ASD may be persistent and difficult to overcome, the company added.
“We are very pleased that the FDA has granted Breakthrough Therapy Designation for Balovaptan, in recognition of its early promise for individuals with ASD,” Sandra Horning, Roche’s chief medical officer and head of global product development, said in a statement. “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.”
