Pfizer’s XELJANZ® (Tofacitinib) Receives EU Approval for Fifth Indication: Active Ankylosing Spondylitis
Nov 20, 2021 01:07
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01:07
Pfizer
Pharmaceutical R&D Developer
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
Ankylosing Spondylitis (AS, Image Source: HealthCentral.com)
News on November 18, 2021 /BioValleyBIOON/ --PfizerPfizer recently announced that the European Commission (EC) has approved the anti-inflammatory drugXeljanz (tofacitinib, Tofacitinib)A new indication: for the treatment of active disease with inadequate response to conventional therapyAnkylosing Spondylitis (AS)Adult patients.
It is worth mentioning that,Xeljanz is the first and only oral JAK inhibitor approved in the EU for five indications, the most among all JAK inhibitors., The four previously approved indications include: (1) Moderate to severe active rheumatoidRheumatoid Arthritis(1) Adult patients with RA; (2) Adult patients with active psoriatic arthritis (PsA); (3) Adult patients with moderate to severe active ulcerative colitis (UC); (4) Patients aged 2 years and above with active polyarticular juvenile idiopathic arthritis (pcJIA) and juvenile PsA.
This AS indication approval is based on the positive results of a Phase 3 clinical study (A3921120). The data showed that, according to the Assessment of SpondyloArthritis international Society (ASAS) criteria,At week 16 of treatment, compared with placebo, Xeljanz achieved the primary endpoint (ASAS20 response) and key secondary endpoint (ASAS40 response).
A3921120 is a multicenter, double-blind, placebo-controlled Phase 3 study conducted in 270 adult patients with active AS who meet the modified New York criteria for AS (MNY) and have had an inadequate response to or were intolerant of two or more non-steroidal anti-inflammatory drugs (NSAIDs). In the study, patients were randomly assigned to receive either 5 mg of Xeljanz or a placebo twice daily for 16 weeks, with a total of 269 patients receiving treatment. Eligible patients who completed the 16-week double-blind treatment period were assigned to receive open-label 5 mg of Xeljanz twice daily for an additional 32 weeks, followed by a 4-week follow-up period.
The results showed,The study met the primary endpoint: at week 16 of treatment, the proportion of patients in the Xeljanz treatment group achieving an ASAS20 response was significantly higher compared to the placebo group (56.4% vs 29.4%; p＜0.0001). Additionally, the proportion of patients achieving an ASAS40 response was significantly higher in the Xeljanz treatment group compared to the placebo group (40.6% vs 12.5%; p＜0.0001).This is a key secondary endpoint of the study. ASAS20/40 is used to determine improvement or treatment response. In the study, the most common adverse events occurring in >5% of patients in any treatment group included: upper respiratory tract infection, nasopharyngitis, diarrhea, elevated alanine aminotransferase (ALT), arthralgia, and headache.
Ankylosing Spondylitis (AS) is a chronic inflammatory disease that affects both men and women in early adulthood. The first symptoms usually occur before the age of 30, rarely appearing after 45. Symptoms of AS include back and buttock pain and stiffness. Over time, some patients may develop fusion of the spinal vertebrae. AS can cause severe chronic pain for patients and negatively impact health-related quality of life.
The active pharmaceutical ingredient in Xeljanz is tofacitinib, an oral JAK inhibitor that selectively inhibits JAK kinases and blocks the JAK/STAT pathway, a signal transduction pathway stimulated by cytokines. This pathway is involved in many important biological processes such as cell proliferation, differentiation, apoptosis, and immune regulation.
In the Chinese market, Xeljanz was approved for marketing in March 2017 for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to or intolerance to MTX therapy. Xeljanz can be used in combination with MTX or other non-biologic DMARDs. The recommended dose is 5mg, taken orally twice daily with or without food. This approval makes Xeljanz a treatment option for RA in the Chinese market.Rheumatoid ArthritisThe first JAK inhibitor for RA. (Bioon.com)
