FDA accepts Teva, Medincell’s supplemental application for UZEDY as bipolar I disorder treatment

Investing.com -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical (TADAWUL:2070) Industries (NYSE:TEVA) Ltd. (NYSE and TASE: TEVA), and Medincell ( Euronext (EPA:ENX): MEDCL), announced on February 25, 2025, that the U.S. Food and Drug Administration (FDA) accepted the supplemental New Drug Application (sNDA) for UZEDY. This long-acting injectable suspension is proposed for the maintenance treatment of bipolar I disorder (BP-I) in adults.

UZEDY is currently approved for use every one or two months as a subcutaneous long-acting injectable (LAI) for the treatment of schizophrenia in adults in the U.S. The sNDA is based on leveraging the existing clinical data for UZEDY, coupled with the FDA’s previous findings of safety and efficacy of past risperidone formulations approved for the treatment of BP-I.

Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical (TASE:BLWV) Officer at Teva, said, "Since the FDA approval of UZEDY almost two years ago, it has proven to be an important treatment option for people living with schizophrenia. Today’s filing demonstrates the potential of UZEDY’s clinical profile as a long-acting treatment for bipolar-I, a complex mental health disorder that significantly affects a person’s mood, behavior, and overall state of mind. Debilitating manic and depressive symptoms and signs can also occur."

Teva will lead the regulatory process and be responsible for potential commercialization of UZEDY for BP-I, with Medincell eligible for royalties on net sales.

Dr. Richard Malamut, Chief Medical Officer at Medincell, highlighted the importance of LAIs in the CNS field today. He mentioned that nonadherence remains a major barrier to effective care in bipolar I disorder and schizophrenia, a problem UZEDY has the potential to help.

UZEDY was approved in the U.S. for the treatment of schizophrenia in adults in 2023. The efficacy and long-term safety and tolerability of UZEDY for the treatment of schizophrenia have been evaluated in two Phase 3 pivotal studies: TV46000-CNS-30072 (the RISE Study – The Risperidone Subcutaneous Extended-Release Study) and TV46000-CNS-30078 (the SHINE Study – Safety in Humans of TV-46000 sc INjection Evaluation).

However, the safety and efficacy of UZEDY for BP-I are not established yet, and UZEDY is not approved by any regulatory authority for this indication.

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