Express Pfizer’s JAK inhibitor gains its fifth indication for the treatment of active ankylosing spondylitis

▎The content team editor of WuXi AppTec On December 14, 2021, Pfizer announced that the US FDA has approved the supplementary new drug application (sNDA) for the oral small molecule JAK inhibitor tofacitinib (tofacitinib, English trade name Xeljanz) It is used to treat adult patients with active ankylosing spondylitis (AS) who have insufficient response or intolerance to one or more tumor necrosis factor (TNF) blockers
.

The press release states that tofacitinib is the first oral JAK inhibitor approved by the FDA for five indications
.

AS is a chronic inflammatory disease, and symptoms usually occur before the age of 30
.

Symptoms of AS include back and hip pain and stiffness
.

Over time, some patients may experience spinal fusion
.

The disease can cause severe chronic pain to patients and negatively affect health-related quality of life
.

Tofacitinib is a JAK inhibitor developed by Pfizer, which can effectively inhibit the activity of JAK1 and JAK3 and block the signal transduction of a variety of inflammatory cytokines
.

Previously, it has been approved by the FDA to treat four indications, including rheumatoid arthritis (RA), psoriatic arthritis (PsA), adult patients with ulcerative colitis, and polyarticular juvenile idiopathic patients over 2 years old Patients with arthritis (pcJIA)
.

Tofacitinib has been studied in more than 50 clinical trials worldwide
.

This approval is based on positive data obtained from a multi-center, randomized, double-blind, placebo-controlled Phase 3 clinical trial
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The trial enrolled 269 adult patients with active AS
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The trial reached its primary endpoint, that is, at week 16, compared with the placebo group (29.
4%, n=40), patients who received 5 mg of tofacitinib twice daily had a significantly higher proportion of ASAS20 responses (56.
4%, n=75, p<0.
0001)
.

In addition, the proportion of patients in the tofacitinib group who achieved an ASAS40 response (40.
6%, n=54, p<0.
0001) was also significantly higher than that in the placebo group (12.
5%, n=17)
.

ASAS20/40 is a standard tool used to evaluate the clinical improvement effect of AS patients
.

In terms of safety, the safety characteristics observed in AS patients are consistent with those observed in RA and PsA patients
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"We are proud to provide a treatment option for ankylosing spondylitis that does not require injections or infusions
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" said Mike Gladstone, Pfizer Global President of Inflammation and Immunology.
"This regulatory approval affirms the clinical value and benefits of tofacitinib.
Functional
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It is the first JAK inhibitor approved by the FDA for the treatment of 5 inflammatory diseases
.

"Reference: [1] US FDA Approves Pfizer's XELJANZ® (tofacitinib) for the Treatment of Active Ankylosing Spondylitis.
Retrieved December 14, 2021, from https:// -detail/us-fda-approves-pfizers-xeljanzr-tofacitinib-treatment-0 Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
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