Pfizer, Inc.PFE announced top-line results from a head-to-head study comparing its rheumatoid arthritis (RA) drug Xeljanz with AbbVie, Inc.'s ABBV Humira.
Xeljanz (5 mg twice daily), a JAK inhibitor, is presently approved as a second-line treatment for the treatment of 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.
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.
Pfizer's shares are up 3.5% so far this year, in line with the Zacks classified Large-Cap Pharma industry.
Overall safety results from these studies were found to be consistent with those observed in the broader rheumatology development program for Xeljanz.
Xeljanz sales in 2016 were $927 million, up 77% from the prior-year quarter. Xeljanz (5 mg, twice daily) is under regulatory review in the EU.
Xeljanz is 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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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
