Pfizer, Inc.’s PFE rheumatoid arthritis (RA) drug, Xeljanz (5 mg taken twice daily) has received marketing approval in China to be used in combination with methotrexate (MTX) or other non-biologic disease-modifying antirheumatic drugs (DMARDs).
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.
Pfizer’s shares are up 6.6% so far this year, almost in line with the Zacks classified Large-Cap Pharma industry’s return of 6.5%.
Xeljanz did well last year with sales of $927 million, up 77% from prior year. Xeljanz (5 mg, twice daily) is under regulatory review in the EU.
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.
Pfizer carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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