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J&J's Janssen gets CRL for antipsychotic sNDA to include long term effectiveness data

May 13, 2015 1:00 PM ETJohnson & Johnson (JNJ) StockJNJBy: Douglas W. House, SA News Editor
  • Janssen Pharmaceuticals (JNJ +0.1%) receives a Complete Response Letter (CRL) from the FDA regarding its supplemental New Drug Application (sNDA) for its long-acting antipsychotic Invega Sustenna (paliperidone palmitate). It was seeking an expanded label to include data showing treatment with the drug is effective six months longer than other commonly prescribed oral antipsychotics in people with schizophrenia.
  • The FDA issues a CRL when it determines that a regulatory application is not approvable in its present form.
  • The data supporting the sNDA was based on the PRIDE study which compared Invega Sustenna to other meds within the context of a real world setting. The primary endpoint was time to treatment failure, which was more broadly defined to include psychiatric hospitalization, arrest/incarceration, suicide, treatment supplementation and increased level of psychiatric services, in addition to the typical endpoints of safety, tolerability and lack of efficacy.
  • Invega Sustenna was originally cleared by the FDA in July 2009. It generated almost $1.3B in sales over the past four quarters.
  • Previously: Janssen seeks expanded label for Invega Sustenna (July 14, 2014)

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