Pfizer: FDA Approves Xeljanz to Treat Active Polyarticular Course Juvenile Idiopathic Arthritis

   By Stephen Nakrosis

Pfizer Inc. on Monday said the U.S. Food and Drug Administration approved its Xeljanz to treat children and adolescents 2 years and older with active polyarticular course juvenile idiopathic arthritis.

The company said two formulations of Xeljanz, or tofacitinib, were approved by the FDA, one a tablet and the other an oral solution. The company also said 5 mg tablets will be available immediately, while the oral solution is expected to be available by the end of the first quarter of next year.

Pfizer said the approval "makes Xeljanz the first and only Janus kinase inhibitor approved in the U.S. for the treatment of pcJIA."

According to Pfizer, Juvenile idiopathic arthritis is a chronic inflammatory disease that affects about 300,000 children in the U.S. "Polyarticular JIA is characterized by arthritis in five or more joints and affects both the small joints of the hands and feet, and large joints like the knees, hips and ankles," Pfizer said.

--Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

(END) Dow Jones Newswires

September 28, 2020 18:48 ET (22:48 GMT)

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