US regulators have accepted Teva Pharmaceuticals and MedinCell’s New Drug Application (NDA) for TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) for the treatment of schizophrenia.
The acceptance is based on Phase 3 data from two pivotal studies: TV46000-CNS-30072 (the RISE Study – The Risperidone Subcutaneous Extended-Release Study) and TV46000-CNS-30078 (the SHINE Study – A Study to Test if TV-46000 is Safe for Maintenance Treatment of Schizophrenia).
These studies evaluated the efficacy and long-term safety and tolerability of TV-46000 as a treatment for patients with schizophrenia. Results will be shared at future scientific conferences and in peer-reviewed publications.
“The advancements made in managing mental health conditions over the past decade have been shaped by offering patients new treatment options. Now, we are taking the same approach with long-acting treatments, using advanced science to improve disease outcomes for those living with Schizophrenia,” said Dr. Hafrun Fridriksdottir, Executive Vice President, Global R&D, at Teva.
“We’re pleased to share news of this progress as we move one step closer to potentially bringing a new treatment option to patients in need.”
Teva will continue to lead the clinical development and regulatory process and be responsible for commercialisation of this candidate treatment, with MedinCell eligible for development milestones, royalties on net sales and future commercial milestones.
“NDA file acceptance marks a major milestone for MedinCell, for our extended-release injectable technology, and for patients living with schizophrenia,” said Christophe Douat, CEO of MedinCell.
“Through our strategic collaboration with Teva, we move one-step closer towards helping patients and care-providers gain access to our extended-release subcutaneously injectable risperidone.”