Pfizer’s Xeljanz (tofacitinib) Receives the US FDA’s Approval for Active Polyarticular Course Juvenile Idiopathic Arthritis

 Pfizer’s Xeljanz (tofacitinib) Receives the US FDA’s Approval for Active Polyarticular Course Juvenile Idiopathic Arthritis

Pfizer’s Xeljanz (tofacitinib) Receives the US FDA’s Approval for Active Polyarticular Course Juvenile Idiopathic Arthritis

Shots:

  • The approval is based on P-III study including 2 phases assessing tofacitinib (5mg or 1mg/mL oral solution, bid) for 44wks. The 2phases includes an 18 wks. open-label, run-in phase study of 225 patients and a 26wks. PBO controlled withdrawal study of 173 patients
  • Results: the study met its 1EP showing ACR30 response at the end of the run-in phase; the occurrence of disease flare in patients (31% vs 55%) @44wks. The approval makes Xeljanz the first and only JAK inhibitor approved in the US for pcJIA
  • The US FDA has approved the two formulations of Xeljanz (a tablet and an oral solution) and are dosed based on weight. The oral solution is expected to be available by the end of Q1’21 while the tablets (5mg) are available instantly

Click here ­to­ read full press release/ article | Ref: Pfizer | Image: CNC

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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