Regulators on Tuesday approved Pfizer's Xeljanz treatment for rheumatoid arthritis, one of the company's potentially most lucrative experimental drugs, which is now poised to compete with Abbott Laboratories' top-selling Humira.
The Food and Drug Administration said it had approved Pfizer's pill for patients with moderate to severe rheumatoid arthritis who did not benefit from or were unable to tolerate the standard oral treatment, methotrexate. Xeljanz can be used by itself or in combination with methotrexate and certain other treatments.
Industry analysts have predicted that Pfizer's drug, which works differently from current treatments and is better known by its chemical name, tofacitinib, could eventually capture annual sales of up to $3 billion. The revenue is sorely needed, as sales fall of Pfizer's Lipitor cholesterol fighter and other Pfizer medicines face cheaper generics.
As a twice-daily pill, Xeljanz may be preferred by some patients over Abbott's $8 billion-a-year Humira, which is given by injection every other week.
But Abbott has said Humira sales will continue growing by leaps and bounds, despite competition from Xeljanz.
The F.D.A. approved a 5-milligram dose of Xeljanz, given twice a day.
But the agency said further safety data was needed to assess a 10-milligram, twice-daily dose, that Pfizer had also put before regulators.
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