Pfizer Inc. PFE announced that the FDA has approved the label expansion of its JAK inhibitor, Xeljanz (tofacitinib), to include a new indication – moderately to severely active ulcerative colitis (“UC”). The drug is approved for the treatment of adult patients with recommended a dose of 10 mg twice-daily for at least eight weeks.
The approval was expected as the FDA Gastrointestinal Drugs Advisory Committee had adopted a positive vote in a meeting in March recommending the approval of the supplemental new drug application (sNDA) filed in July last year seeking label expansion of Xeljanz in UC.
Xeljanz is already marketed for the treatment of rheumatoid arthritis and active psoriatic arthritis. In the first quarter of 2018, Xeljanz sales were $326 million, up 30.4% from the year-ago period. The label expansion in the UC indication is likely to boost its sales further.
Shares of Pfizer have lost 0.5% so far this year, compared with a 6% decrease for the industry it belongs to.
The approval was based on data from three pivotal studies – OCTAVE Induction 1, OCTAVE Induction 2 and OCTAVE Sustain – which demonstrated that statistically significant and greater proportion of patients achieved remission when treated with Xeljanz compared to a placebo.
Pfizer is currently evaluating Xeljanz in an open label long-term extension study, OCTAVE Open.
However, there are several blockbuster drugs in the inflammatory segment approved for UC, which includes Johnson & Johnson’s JNJ Remicade and Simponi, AbbVie’s ABBV Humira and Shire’s SHPG Lialda. Moreover, many biotech companies are developing their candidates for the treatment for UC. Hence, competition is likely to increase in this segment.
Pfizer currently has 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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