Pfizer Inc. may have a strong convenience advantage with its oral rheumatoid arthritis drug Xeljanz (tofacitinib), but the firm could face a long, slow drive to gain market share from the popular injectable tumor necrosis factor inhibitors due to lingering uncertainties about safety and the need for frequent patient monitoring.
To some extent the Nov. 6 FDA approval of the first Janus kinase inhibitor for RA, two weeks ahead of the user fee deadline, gives Pfizer some advantages. For one, regulators did not limit the indication to patients who had failed on a TNF inhibitor, as recommended by the Arthritis Drugs Advisory Committee during its May review Also see "Panel Backs Pfizer’s Tofacitinib For RA, With Narrower Indication" - Pink Sheet, 10 May, 2012.
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