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Priority Review for Janssen Drug

The US Food and Drug Administration (FDA) has approved under priority review Janssen Pharmaceuticals’ New Drug Application (NDA) for the three-month long-acting atypical antipsychotic Invega Trinza.

Priority review is a designation for drugs that, if approved, would offer significant improvement in the treatment of serious conditions. In a long-term maintenance trial, 93 percent of patients treated with Invega Trinza did not experience a significant return of schizophrenia symptoms, according to Janssen. Based on positive efficacy, Janssen concluded this study early following the recommendation of an Independent Data Monitoring Committee (IDMC).

“With a dosing interval that can be measured in seasons, not days, people living with schizophrenia and their treatment teams can focus on recovery goals beyond short-term symptom control,” said trial investigator Joseph Kwentus, MD, Precise Research Centers. “Recovery looks different for everyone, and the long-term symptom control offered by Invega Trinza can help patients work toward their own personal goals.”

Janssen expects that Invega Trinza will be commercially available in the US by mid-June.

Source: Janssen