Oral Dosing May Not Be Enough To Win Speedy Adoption Of Pfizer’s RA Pill Xeljanz

Pfizer’s newly approved oral RA therapy Xeljanz has an oral advantage over established immune modulators, which all are delivered by needle, but safety questions may slow its adoption.

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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