Pfizer, Inc. (PFE - Free Report) announced top-line results from a head-to-head study comparing its rheumatoid arthritis (RA) drug Xeljanz with AbbVie, Inc.’s (ABBV - Free Report) 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 - Free Report) Remicade and Amgen, Inc.’s (AMGN - Free Report) 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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Pfizer, Inc. (PFE - Free Report) announced top-line results from a head-to-head study comparing its rheumatoid arthritis (RA) drug Xeljanz with AbbVie, Inc.’s (ABBV - Free Report) 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 - Free Report) Remicade and Amgen, Inc.’s (AMGN - Free Report) 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.
Just Released – Driverless Cars: Your Roadmap to Mega-Profits Today
In this latest Special Report, Zacks’ Aggressive Growth Strategist Brian Bolan explores a full-blown technological breakthrough in the making – autonomous cars. He also spotlights 8 stocks with tremendous gain potential to feed off this phenomenon. Click to see the stocks right now >>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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