Janssen’s Invega Hafyera (paliperidone palmitate) Receives the US FDA’s Approval for the Treatment of Schizophrenia

September 2, 2021 Auto Bot approval, FDA, Janssen, regulatory, Schizophrenia 0

Shots:

  • The approval is based on a P-III study that evaluates Invega hafyera (q6mos., twice-yearly injectable) vs Invega trinza in 702 adults in a ratio (2:1) aged 18-70yrs. with schizophrenia from 20 countries
  • The results showed non-inferiority on 1EPs of time to 1st relapse @12mos. in ITT & per-protocol analysis sets., patients were relapse-free (92.5% vs 95%) @12mos. & safety profile was consistent with previous studies with no new safety signals were observed
  • Additionally, patients who take Invega Hayfera must first be treated with Invega Sustenna for 4mos. or Invega Trinza for 1mos. injection cycle. Janssen’s CarePath provides a comprehensive support program to help patients on Invega hafyera

Click here to­ read full press release/ article | Ref: PR Newswire | Image: Reuters

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