FDA approves Pfizer's Xeljanz for RA

The FDA on Tuesday approved Pfizer's Xeljanz (tofacitinib) for the treatment of patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate. "Xeljanz provides a new treatment option for adults suffering from the debilitating disease of RA who have had a poor response to methotrexate," remarked Badrul Chowdhury, the FDA’s director of the Division of Pulmonary, Allergy, and Rheumatology Products.

While Pfizer had sought approval of two different doses of the JAK inhibitor, regulators approved only the 5-milligram dose to be taken twice a day. In August, the agency extended its review of the therapy in order to assess additional data analyses recently submitted by the company. The additional data were subsequently classified as a major amendment to the application and the decision date was moved to November 21.

The drug was approved with a risk evaluation and mitigation strategy, requiring safety information on the drug's package insert label and a communication plan to inform healthcare workers about its risks, which include an increased risk of serious infections, tuberculosis, cancers and lymphoma. The FDA is also requiring Pfizer to conduct a postmarketing study to evaluate Xeljanz's long-term effects on heart disease, cancer and serious infections. The drugmaker will also provide additional data on a 10-milligram dose of the therapy in patients with RA.

Sanford Bernstein analyst Tim Anderson remarked that "it is understandable why (new) patients might prefer an oral therapy versus one that requires needle-based delivery," although he noted that patients already benefiting from other medicines are unlikely to switch to a new product. Anderson suggested that Xeljanz would likely cost $25 000 a year, in line with injectable treatments such as Abbott's Humira (adalimumab), Amgen's Enbrel (etanercept) and Johnson & Johnson's Remicade (infliximab). However, Pfizer spokeswoman Victoria Davis noted that the drug will cost $2055 for a 30-day supply at wholesale, which is less than similar treatments currently on the market.

Leerink Swann & Co. analyst Seamus Fernandez predicted that Xeljanz may generate $2.3 billion in annual sales by 2018. Anderson indicated that sales could be considerably higher if the product is also eventually approved for psoriasis, inflammatory bowel disease and other inflammatory conditions.

For further analysis, read ViewPoints: The path forward for Pfizer’s Xeljanz and ViewPoints: In Xeljanz, Pfizer delivers key post-Lipitor approval.

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