Monday, February 5, 2018

FDA Grants ‘Breakthrough Therapy’ Status To Potential Autism Drug

Swiss drug maker Roche said this week that the FDA has granted its breakthrough therapy designation for the development of balovaptan, a medication with the potential to improve “core social interaction and communication” in those with autism.
The FDA uses the breakthrough therapy designation to speed the development of promising medications for serious conditions. It offers drugmakers added assistance and priority from the federal agency as they work to get a new treatment to market.
There are only two drugs — risperidone and aripripazole — with FDA approval to treat irritability related to autism. No drugs are currently approved to address core symptoms of the condition.