Janssen files to expand label for Invega Sustenna to show delayed time to relapse in schizophrenia
US health care giant Johnson & Johnson’s (NYSE: JNJ) Europe-based subsidiary Janssen has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration for new labeling of its Invega Sustenna (paliperidone palmitate).
It seeks a label change that, should it receive approval, would include new data showing significantly delayed time to relapse in schizophrenia patients prescribed once-monthly atypical long-acting antipsychotic Invega Sustenna compared to selected oral antipsychotic therapies.
The submission is supported by a landmark prospective, randomized clinical trial to evaluate treatments for schizophrenia in the context of many ‘real world’ issues faced by patients in their everyday lives, including recent incarceration. The Paliperidone Palmitate Research in Demonstrating Effectiveness study (PRIDE), was a 15-month multicenter study of 444 adults with schizophrenia, and who had recently been incarcerated.
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