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Pfizer's Arthritis Drug Xeljanz Gets Marketing Nod in Europe
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Pfizer, Inc.’s (PFE - Free Report) 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.
Pfizer’s shares are up 5.3% so far this year, comparing unfavorably with the Zacks classified Large-Cap Pharma industry’s gain of 6.2%.
Xeljanz did well last year with sales of $927 million, up 77% from the prior year.
Last month, Pfizer announced top-line results from a head-to-head study comparing Xeljanz with AbbVie, Inc.’s (ABBV - Free Report) 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 - Free Report) Remicade and Amgen, Inc.’s (AMGN - Free Report) Enbrel that Pfizer markets outside the U.S. and Canada.
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Pfizer's Arthritis Drug Xeljanz Gets Marketing Nod in Europe
Pfizer, Inc.’s (PFE - Free Report) 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.
Pfizer’s shares are up 5.3% so far this year, comparing unfavorably with the Zacks classified Large-Cap Pharma industry’s gain of 6.2%.
Xeljanz did well last year with sales of $927 million, up 77% from the prior year.
Last month, Pfizer announced top-line results from a head-to-head study comparing Xeljanz with AbbVie, Inc.’s (ABBV - Free Report) 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 - 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.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market. Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020. Click here for the 6 trades >>