PETAH TIKVA (dpa-AFX) - Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries (TEVA), announced the FDA accepted the New Drug Application for ecopipam, with a targeted action date late in the first quarter of 2027. Ecopipam is an investigational therapy for the treatment of pediatric patients with Tourette syndrome. The company said the NDA acceptance for ecopipam is supported by positive Phase 2b and 3 data.
Eric Hughes, Executive Vice President, Global R&D and Chief Medical Officer of Teva, said: 'If approved, ecopipam would be the first new therapy for Tourette syndrome in more than 10 years and the first novel mechanism of action in more than 50 years, offering patients and families a long-awaited new treatment option.'
In pre-market trading on NYSE, Teva Pharmaceutical shares are up 3.20 percent to $37.76.
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