MedinCell’s partner Teva today announced refiling for approval of mdc-IRM and confirmed planned launch in the U.S. in H1 2023 

November 3, 2022

MedinCell’s partner, Teva, today announced that it recently completed the re-submission to a New Drug Application to the U.S. FDA for mdc-IRM, a risperidone subcutaneous Long-Acting Injectable (LAI) for the maintenance treatment of schizophrenia using MedinCell’s proprietary technology. 

Following a complete response letter from the FDA in mid-April, Teva worked quickly to align on a path forward and to conduct a complete quality check of all clinical data. 

Teva now expects review and approval to take up to six months post resubmission. Teva is confident that it will achieve FDA approval and launch mdc-IRM under the brand name UZEDYTM in the first half of 2023. Teva continues to be committed to working closely with the Agency to bring this new and important risperidone subcutaneous LAI product to the schizophrenia patients who need it. 

Initiation of Phase 3 activities for a second LAI antipsychotic using the same LAI technology was notified to MedinCell by Teva in September 2022. It will assess the efficacy and safety of potentially the first subcutaneous LAI formulation of olanzapine for the treatment of patients with schizophrenia. 

For each product, MedinCell is potentially eligible for development and commercial milestones (up to $122 million), and royalties on net sales. 

Session en français

Rendez-vous le mardi 12 septembre à 18h00 pour la diffusion en direct de l'Assemblée Générale mixte

English session

On Tuesday September 12 at 6:00 p.m. live of the Combined General Meeting (in French)

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