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FDA Approves First And Only Twice-Yearly Schizophrenia Drug

Benzinga · 09/01/2021 12:30
  • The FDA has approved a long-acting schizophrenia drug from Janssen, a unit of Johnson & Johnson (NYSE:JNJ)
  • Previously known as paliperidone palmitate, Invega Hafyera is a twice-yearly injectable. It's the first and only twice-yearly med for the condition. 
  • The new long-acting regime joins J&J's existing one-month and three-month formulations, dubbed Invega Sustenna and Invega Trinza, respectively, plus a two-week injection known as Risperdal Consta.
  • The FDA based its approval on the results from a 702-patient Phase 3 trial. In that study, investigators found that the six-month formulation's performance held up with those already using the three-month injection to avoid relapse. 
  • Related content: Benzinga's Full FDA Calendar.
  • Price Action: JNJ shares are up 0.10% at $173.30 during the market session on the last check Wednesday.