Pfizer's Once-Daily Tofacitinib Extended-Release Tablets Receive New Indication Approval in China

On February 9, the official website of the National Medical Products Administration (NMPA) showed that Pfizer's Tofacitinib Citrate Extended-Release Tablets received approval for a new indication in China.

Tofacitinib is a JAK inhibitor developed by Pfizer. The currently approved indications worldwide include rheumatoid arthritis, ulcerative colitis, psoriatic arthritis, juvenile idiopathic arthritis, and ankylosing spondylitis.

Tofacitinib tablets were approved by the FDA in November 2012 under the brand name Xeljanz, taken orally twice daily; extended-release tablets were approved by the FDA in December 2019 for the treatment of adult patients with moderately to severely active ulcerative colitis, under the brand name Xeljanz XR, available in 11 mg and 22 mg dosages, taken orally once daily.

Tofacitinib tablets (brand name: Xeljanz) entered the Chinese market in March 2017 for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have had an inadequate response to or intolerance to methotrexate; In August 2021, the extended-release tablet formulation for this indication was approved in China; In April 2022, the second indication of tofacitinib tablets was approved for the treatment of adult patients with active ankylosing spondylitis (AS) who have had an inadequate response to or intolerance to one or more TNF blockers; On October 11, 2022, the third indication of tofacitinib tablets was approved for adult patients with active psoriatic arthritis (PsA) who have had an inadequate response to or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs); Subsequently, on October 18, the extended-release tablet formulation for this indication was also approved for marketing.

Since its launch, the sales of Tofacitinib have been steadily increasing, reaching $2.455 billion in 2021. However, in 2022, there was a decline, with global sales revenue decreasing by 27% year-on-year to $1.796 billion.

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