資料來源：https://www.nasdaq.com/article/pfizers-arthritis-drug-xeljanz-gets-marketing-nod-in-europe-cm766760

Pfizer, Inc. 's PFE rheumatoid arthritis (RA) drug, Xeljanz has received marketing approval in Europe.

The European Commission has approved Xeljanz (5 mg taken twice daily) to be used in combination with methotrexate (MTX) for the treatment of moderate-to-severely active RA in adult patients who have had an inadequate response to or cannot tolerate one or more disease-modifying antirheumatic drugs (DMARDs). Xeljanz has also been approved as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate.

Xeljanz (5 mg twice daily), a JAK inhibitor, is presently approved in the U.S. as a second-line treatment for moderate-to-severely active RA in patients who have had an inadequate response to or cannot tolerate methotrexate. In Feb 2016, the FDA approved a once-daily extended-release (XR) formulation of Xeljanz (11 mg) tablets. Earlier this month, the drug was approved in China.

Last month, Pfizer announced top-line results from a head-to-head study comparing Xeljanz with AbbVie, Inc.'s ABBV Humira.

The phase IIIb/IV ORAL Strategy study (n=1,152) compared Xeljanz (5 mg twice daily) as a monotherapy or in combination with methotrexate (MTX) versus Humira plus MTX. The study demonstrated non-inferiority of Xeljanz plus MTX versus Humira plus MTX, thereby meeting the primary endpoint. However, Xeljanz monotherapy did not demonstrate non-inferiority versus Humira plus MTX, thereby failing to meet the primary endpoint.

Xeljanz is also being studied for the treatment of active psoriatic arthritis (PsA) and ulcerative colitis. Label and geographical expansion will boost the drug's commercial potential significantly.

Blockbuster drugs currently approved to treat RA include Johnson & Johnson's JNJ Remicade and Amgen, Inc.'s AMGN Enbrel that Pfizer markets outside the U.S. and Canada.