FDA Approves Janssen’s Treatment for Adults with Schizophrenia

September 2, 2021

Johnson & Johnson’s Janssen subsidiary has won FDA approval for Invega Hafyera (6-month paliperidone palmitate) as a twice-a-year injectable treatment for adults with schizophrenia.

Before receiving the treatment, patients must first be treated with Invega Sustenna, a once-a-month injection, for at least four months, or with Invega Trinza, a 3-month injection, for at least one cycle.

The approval was supported by results from a late-stage study in 702-participants in which 92.5 percent of patients treated with Invega Hafyera were relapse-free after a year.

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