Janssen Reports sNDA Submission of Paliperidone Palmitate 6-Month (PP6M) to the US FDA for Schizophrenia

November 3, 2020 Auto Bot Janssen, regulatory, reports, Us FDA 0

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

Click here to­ read the full press release/ article | Ref: PRNewswire | Image: Canal Ideal

The post Janssen Reports sNDA Submission of Paliperidone Palmitate 6-Month (PP6M) to the US FDA for Schizophrenia first appeared on PharmaShots.