Johnson & Johnson announced the submission of two supplemental Biologics License Applications, sBLAs, to the U.S. Food and Drug Administration, FDA, seeking approval of TREMFYA for the treatment of children 6 years and older with moderate-to-severe plaque psoriasis, PsO, and children 5 years of age and older with active juvenile psoriatic arthritis. The PsO submission is based on data from the Phase 3 PROTOSTAR study in pediatric patients with moderate to severe plaque PsO and bridging pharmacokinetic data from the Phase 3 VOYAGE 1 and 2 studies in adult patients with moderate to severe plaque PsO. The jPsA submission is based on PK extrapolation analyses from adult PsA studies and TREMFYA efficacy and safety data from the PROTOSTAR study.
Elevate Your Investing Strategy:
- Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on JNJ:
- AstraZeneca (AZN) Sees Its Cancer Drug Added to China’s Reimbursement List
- Janssen treatment of multiple myeloma granted FDA orphan status
- Sanofi (SNY) Is Seeking to Change How It Gives Discounts to Hospitals
- Sanofi planning changes to 340B hospital drug discount plan, WSJ reports
- JNJ seeks FDA approval of subcutaneous induction regimen of Tremfya