FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Roche’s Autism Drug Balovaptan Granted Breakthrough Therapy Designation

Feb. 1, 2018

The FDA awarded Roche’s autism drug Balovaptan (RG7314) breakthrough therapy designation for treating patients with autism spectrum disorder.

Balovaptan, a vasopressin 1a receptor antagonist, has shown early potential and could be the first pharmacotherapy to help alleviate the social and communicative symptoms of ASD.

The agency primarily based its designation on the Vasopressin Antagonist to Improve Social Communication in Autism (VANILLA) study, a Phase II clinical trial of Balovaptan involving adults with ASD that showed the drug was safe and well tolerated by most subjects.

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