FDA hands Pfizer blockbuster approval for rheumatoid arthritis drug tofacitinib

The FDA has handed Pfizer ($PFE) an approval for its oral rheumatoid arthritis drug tofacitinib, which will hit the market soon as Xeljanz. The news will be cheered at Pfizer, which counted the RA drug--pronounced ZELL-janz--as one of its most critical late-stage programs, offering a key sign that its R&D division is back on track after years of pratfalls, setbacks and disasters.

Anaysts expect that the drug can reach peak sales of $2 billion to $3 billion a year, offering some blockbuster relief to a company that has been savaged by generic competition. A Pfizer spokesperson told Bloomberg the drug will cost $2,055 a month, or a bit more than $24,000 a year. 

Now the door is open for Pfizer to start competing with Abbott's ($ABT) number-one selling drug Humira, which is expected to earn $9.5 billion this year. As an oral drug, Xeljanz is likely to look more appealing for many patients compared to an injectable like Humira. But Humira has built up plenty of momentum in this market. 

The news comes well ahead of the agency's delayed PDUFA date of Nov. 21, coming shortly after it got a chance to analyze new data on its Phase III performance. And the approval comes with a catch. The FDA is requiring a post-marketing study that will evaluate two doses of Xeljanz and include a group of patients on another approved treatment to serve as a comparison.

"Xeljanz provides a new treatment option for adults suffering from the debilitating disease of RA who have had a poor response to methotrexate," said Badrul Chowdhury, M.D., Ph.D., director of the division of pulmonary, allergy, and rheumatology products in the FDA's Center for Drug Evaluation and Research. 

There's been some serious skepticism whether Pfizer has demonstrated superior efficacy for tofacitinib over currently used drugs. Since it filed its regulatory package, though, the drug company's R&D wing has offered fresh evidence that the treatment can reduce structural damage for patients. And Pfizer has boasted that it produced the biggest dataset ever for an RA product.

- here's the press release from the FDA
- get the Bloomberg report

Special Report: Tofacitinib - Blockbuster buzz: 15 top therapies in late-stage development

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