FDA Approves New Long-Acting Schizophrenia Treatment

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September 1, 2021 – Invega HafyeraTM (paliperidone palmitate) extended-release injectable suspension is now the first FDA-approved twice-yearly treatment for schizophrenia.

Made by Janssen, the drug is indicated for use in adults who have been adequately treated with:
  • A once-monthly paliperidone palmitate extended-release injectable suspension, such as Janssen's Invega Sustenna®, for at least four months, or
  • An every-three-month paliperidone palmitate extended-release injectable suspension, such as Janssen's Invega Trinza®, for at least one three-month cycle.
  • Recommended dosing is determined based on the patient's prior treatment history. Invega Hafyera should be given via gluteal intramuscular injection by a healthcare professional once every six months.
  • Invega Hafyera has launched at a wholesale acquisition cost (WAC) of $11,760.28 per syringe.