Shots:

• The sNDA submission is based on P-lll Route-6 study assessing PP6M vs PP3M in 702 patients with schizophrenia previously stabilized on corresponding doses of PP1M or PP3M across 20 countries
• Results demonstrated non-inferior efficacy of PP6M to PP3M on the 1EPs of time to relapse at the end of the 12mos. period in both intent-to-treat and per-protocol analysis sets- the safety profile is consistent with no new safety signals
• If approved- PP6M will be the first and only long-acting injectable schizophrenia treatment with a twice-yearly dosing regimen. Additionally- Janssen plans to submit an MAA extension to the EMA for PP6M in the coming months

  Ref: PRNewswire | Image: Janssen