FDA accepts Teva and MedinCell NDA for treatment of schizophrenia


(RTTNews) – Teva Pharmaceuticals, a US subsidiary of Teva Pharmaceutical Industries Ltd. (TEVA) and MedinCell (MEDCL) said Tuesday that the new drug application for TV-46000 / mdc-MRI for the treatment of schizophrenia has been accepted by the United States Food and Drug Administration.

The FDA accepted the NDA based on Phase 3 data from two pivotal studies. These studies evaluated the long-term efficacy, safety and tolerability of TV-46000 as a treatment for patients with schizophrenia.

“Advances in the management of mental health issues over the past decade have been shaped by providing patients with new treatment options. Today we are taking the same approach with long-acting treatments, using cutting-edge science to improve disease outcomes for people living with schizophrenia, “said Dr Hafrun Fridriksdottir, vice-president Executive Chairman, Global R&D, at Teva. “We are delighted to share news of these advancements as we move closer to bringing a new treatment option to patients in need.”

Schizophrenia is a chronic, progressive, and severely debilitating mental disorder that affects the way a person thinks, feels and acts. Patients present with a range of symptoms, which may include delusions, hallucinations, disorganized speech or behavior, and impaired cognitive abilities.

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