Teva on the way to a breakthrough: the drug that may change the treatment of Tourette's

Teva announced that the FDA has accepted its application to approve ecopipam for the treatment of Tourette syndrome in children, granting it an expedited review pathway with a target decision by the end of the first quarter of 2027. The company is advancing its 'Pivot to Growth' strategy. If approved, it would be the first drug in the field with a new mechanism of action in 50 years.

Teva Pharmaceutical Industries announced today (Wednesday) that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ecopipam for the treatment of Tourette syndrome. This is a first-of-its-kind experimental treatment intended for children, and the FDA has granted it an expedited review process, with a target decision date at the end of the first quarter of 2027. The company explains that this milestone advances its 'Pivot to Growth' strategy, leveraging expertise in neuroscience. Tourette syndrome is a chronic neurodevelopmental disorder affecting approximately 100,000 children and adolescents in the U.S. According to company data, only about half of patients receive prescription medication, and only 20%-30% of them continue treatment after one year. Dr. Eric Hughes, Senior Vice President and Head of Global R&D at Teva, stated that if approved, ecopipam would be the first treatment for Tourette syndrome in over a decade and the first with an innovative mechanism of action in this field in more than 50 years.