FDA Expands UZEDY Approval to Bipolar I Disorder

Paris: The FDA has approved UZEDY, the first subcutaneous long-acting risperidone formulation utilizing SteadyTeq™ technology, for maintenance treatment of bipolar l disorder-broadening its use beyond schizophrenia.

UZEDY is the first subcutaneous, long-acting formulation of risperidone that utilizes SteadyTeq™, a copolymer technology proprietary to Medincell that controls the steady release of risperidone.1 Therapeutic blood concentrations are reached within 6-24 hours of a single dose.1 For the BD-I indication, UZEDY is now approved with three once-monthly dosing options (50 mg, 75 mg and 100 mg).

“Adults living with BD-I experience debilitating manic and depressive symptoms, and today’s FDA approval of UZEDY provides a new long-acting formulation of risperidone that may help address existing unmet needs and treatment gaps,” said Chris Fox, Executive Vice President, U.S. Commercial at Teva. “This expanded indication for UZEDY builds on its success in adults living with schizophrenia and demonstrates Teva’s dedication to developing innovative medicines for complex mental health conditions that place a heavy burden on individuals and their caregivers.”

An estimated 1% (or 3,400,000+) of U.S. adults will develop BD-I in their lifetime which is associated with poor long-term outcomes and a substantial increase in mortality compared to the general population from both suicide and cardiovascular disease.

“Bipolar I disorder carries profound implications for a person’s life and is linked to suboptimal long-term outcomes, with treatment adherence to daily oral options frequently presenting as a major impediment to effective care,” said Craig Chepke, MD, DFAPA, Medical Director, Excel Psychiatric Associates and Scientific Director, HMP Global’s Psych Congress events and programs. “The FDA’s decision to expand the indication for UZEDY may help those living with BD-I. As a clinician, I am excited to now have a new treatment option for this complex disease.”

UZEDY was approved in the U.S. for the treatment of schizophrenia in adults in 2023.

“Long-acting injectables are increasingly recognized as key drivers of innovation in CNS therapeutics,” said Christophe Douat, CEO of Medincell. “We’re proud that UZEDY is now available to support patients living with bipolar I disorder. This milestone highlights the exceptional regulatory and commercial execution of our partner, Teva.”

The data reviewed by the FDA to support UZEDY’s approval for the treatment of BD-I includes the Agency’s previous findings of safety and efficacy of past risperidone formulations approved for the treatment of BD-I as well as the efficacy, long-term safety and tolerability of UZEDY for the treatment of schizophrenia which was 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).