Pfizer, Inc. PFE announced positive data from a study, which was conducted to demonstrate the efficacy of its Janus kinase inhibitor (JAK) Xeljanz extended release as a monotherapy after withdrawing use of methotrexate (MTX) in adults with moderately-to-severely active rheumatoid arthritis (RA).
The phase III/IV ORAL Shift study was conducted to evaluate the efficacy and safety of Xeljanz XR 11 mg once daily (QD) as monotherapy after MTX withdrawal compared with Xeljanz XR with continued MTX in RA patients who achieved low disease activity after combination therapy. Data from the study showed that at week 48, Xeljanz XR after MTX withdrawal was non-inferior compared with Xeljanz XR with continued MTX as measured by the primary endpoint. The primary endpoint of the study was to measure the change in the Disease Activity Score from randomization at week 24 to the end of the double-blind MTX withdrawal phase at week 48.
The results are expected to be presented during a late-breaking oral session at the Annual European Congress of Rheumatology. The results of the study, if approved to be included in the label, will give doctors the option to prescribe Xeljanz to RA patients who are unable or unwilling to use MTX.
Xeljanz, a key drug in Pfizer's portfolio, recorded sales of $423 million in the first quarter of 2019, up 34% year over year. Sales growth was driven by continued growth in RA revenues and contributions from the drug's recent expansion into psoriatic arthritis and ulcerative colitis in the United States and only ulcerative colitis in certain developed markets. Xeljanz was approved in the United States for new indications, psoriatic arthritis in December 2017 and ulcerative colitis in May 2018. Xeljanz is also being evaluated in late-stage studies for ankylosing spondylitis.
Pfizer's shares have declined 1.3% this year so far against an increase of 1.9% for the industry .
JAK inhibitors are emerging as a potential treatment option for RA, eczema and other inflammatory diseases. These medicines work by blocking a particular signal of a body's immune response, cytokines, instead of suppressing the immune system as done by disease-modifying antirheumatic drugs. Other JAK inhibitors approved for different autoimmune or inflammatory diseases are Incyte's INCY Jakafi and Eli Lilly's LLY Olumiant.
Several pharma companies are also developing JAK inhibitors including AbbVie's ABBV upadacitinib and Galapagos NV/Gilead's filgotinib, which are in late-stage development
Pfizer currently 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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