FDA Grants ‘Breakthrough Therapy’ Status To Potential Autism Drug
A major pharmaceutical company says it has received a designation from the Food and Drug Administration to help expedite what could be the first drug to treat the core symptoms of autism.
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.
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