Pfizer Submits New NDA in China for Tofacitinib Extended-Release Tablets with Six Phase 3 Trials Ongoing

Source: Medicine Overview

The latest public notice on the website of the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration indicates that Pfizer has submitted a new marketing application in China for its JAK inhibitor, tofacitinib citrate extended-release tablets, which was accepted on May 26. Tofacitinib has been approved overseas for multiple indications; however, in China, it is currently only approved for the treatment of adult patients with rheumatoid arthritis. As one of Pfizer’s core products in the field of autoimmune disease treatment, its Phase 3 clinical trial for plaque psoriasis has been completed, and six additional Phase 3 clinical trials are ongoing, covering various indications such as active psoriatic arthritis and juvenile idiopathic arthritis.

Image source: CDE screenshot

Janus kinases (JAKs) belong to the cytoplasmic tyrosine kinase family and comprise four subtypes: JAK1, JAK2, JAK3, and TYK2, with overlapping binding partners among these subtypes. JAK kinases are considered to play a critical role in inflammation, as they are involved in the signaling of more than 50 cytokines and growth factors, many of which drive immune-mediated responses. JAK inhibitors have demonstrated efficacy in the treatment of certain inflammatory and autoimmune diseases.

Tofacitinib is a novel oral JAK inhibitor developed by Pfizer, Inc. It works by inhibiting the JAK pathway, thereby suppressing cell signal transduction as well as related gene expression and activation, ultimately leading to clinical improvement. In the United States, Pfizer’s tofacitinib has been approved for the treatment of multiple indications, including rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis.

In China, tofacitinib (brand name Xeljanz) was first approved in March 2017 for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to or intolerance to methotrexate. It can be used in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDs).

According to the public information on the Chinese Drug Clinical Trial Registration and Information Publicity Platform, Pfizer has registered ten clinical trials for tofacitinib in China, including six international multicenter Phase 3 clinical trials and one Phase 3 clinical trial conducted exclusively in Chinese patients. These trials cover various indications such as plaque psoriasis and active psoriatic arthritis. Details are as follows:

A randomized, double-blind, international, multicenter Phase 3 clinical study to evaluate the efficacy and safety of oral tofacitinib in Asian patients with moderate-to-severe chronic plaque psoriasis has been completed.

A randomized, double-blind, Phase 3 clinical study in China is ongoing to evaluate the efficacy and safety of tofacitinib tablets in patients with active psoriatic arthritis.

Two single-arm, open-label, non-randomized, international, multicenter Phase 3 clinical trials, with the primary objectives of determining the long-term safety and tolerability of tofacitinib tablets/oral solution in the treatment of juvenile idiopathic arthritis (JIA), respectively, and the secondary objective of evaluating the sustained efficacy of tofacitinib tablets/oral solution in the treatment of JIA. The studies are ongoing, and recruitment has not yet commenced.

Two randomized, double-blind, international, multicenter Phase 3 clinical studies are designed to evaluate the efficacy, safety, tolerability, and pharmacokinetics of tofacitinib tablets and tofacitinib oral solution for the treatment of systemic juvenile idiopathic arthritis (sJIA), respectively. These studies are ongoing and have not yet begun recruitment.

A randomized, double-blind, international, multicenter Phase 3 clinical study to evaluate the efficacy and safety of tofacitinib tablets in patients with active ankylosing spondylitis (AS). The data obtained will be used to support clinical registration. The study is ongoing, and patient enrollment has not yet commenced.

Congratulations to Pfizer on the submission of a new marketing application in China for its Tofacitinib Citrate Extended-Release Tablets. We hope the drug will be approved soon to benefit more patients.

References

[1] Center for Drug Evaluation, National Medical Products Administration of China. Retrieved May 26, 2020, from http://www.cde.org.cn/news.do?method=changePage&pageName=service&frameStr=3

[2] Chinese Drug Clinical Trial Registration and Information Publicity Platform. May 26, 2020, from http://www.chinadrugtrials.org.cn/eap/clinicaltrials.searchlist

(Original Title: Pfizer Submits a New Marketing Application for Tofacitinib in China, with Six Phase 3 Clinical Trials Underway Simultaneously!)

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