Teva on the path to a breakthrough: the drug that may change the treatment of Tourette syndrome
The FDA has accepted for review Teva's application for the approval of Aukopipam for the treatment of children with Tourette syndrome and has granted it an accelerated pathway. If approved, it could be the first drug in the field with a new mechanism of action in over 50 years.
Teva Pharmaceutical Industries Ltd. announced on Wednesday that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Aukopipam for the treatment of Tourette syndrome. This is the first experimental treatment of its kind intended for children, with the FDA granting the drug an accelerated review process and setting the target decision date for the end of the first quarter of 2027.
The company explains that this milestone advances Teva's 'Pivot to Growth' strategy, utilizing the company's expertise in neuroscience to support patients, especially in areas where there is a significant unmet medical need.
Tourette syndrome is a chronic neurodevelopmental disorder affecting approximately 100,000 children and adolescents across the United States. 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, Executive Vice President, Head of Global R&D and Chief Medical Officer at Teva, stated:
"The acceptance of the NDA for Aukopipam is an important milestone in the progress of Teva's 'Pivot to Growth' strategy, bringing us closer to providing a solution for children and their families dealing with Tourette syndrome. If approved, Aukopipam will be the first treatment for Tourette syndrome in over a decade and the first treatment with an innovative mechanism of action in this field in over 50 years, offering patients and families a new treatment option they have been waiting for for a long time."
