FDA Acceptance of Supplemental New Drug Application for UZEDY(R) Extended-Release Injectable Suspension as a Treatment of Bipolar I Disorder
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Medincell (Euronext: MEDCL) announced that the supplemental New Drug Application (sNDA) for UZEDY extended-release injectable suspension for the maintenance treatment of BP-I in adults has been accepted for filing by the U.S. Food and Drug Administration (FDA).
The sNDA is based on leveraging the existing clinical data for UZEDY coupled with the Agency’s previous findings of safety and efficacy of past risperidone formulations approved for the treatment of BP-I.
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.
said Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva.
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.
Long-acting injectables are key drivers of innovation in the CNS field today. In bipolar I disorder, as in schizophrenia, nonadherence remains a major barrier to effective care, one that UZEDY has the potential to help. We are proud to partner with Teva to deliver treatment options aimed at meeting unmet medical needs.
said Dr. Richard Malamut, Chief Medical Officer at Medincell.
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).
The safety and efficacy of UZEDY for BP-I are not established and UZEDY is not approved by any regulatory authority for this indication.
For more information, read the original press release.
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