The Food and Drug Administration cleared Pfizer’s treatment, tofacitinib, to be sold as Xeljanz, for adults with moderate to severe rheumatoid arthritis who don’t respond well to other drugs, the agency said today in a statement.
Xeljanz inhibits part of the immune system that can cause rheumatoid arthritis. It may generate $2.3 billion in annual sales for New York-based Pfizer by 2018, estimated Seamus Fernandez, an analyst with Leerink Swann & Co. in Boston. It would compete with Humira and Johnson & Johnson (JNJ:US)’s Remicade.
“Xeljanz provides a new treatment option for adults suffering from the debilitating disease of RA who have had a poor response to methotrexate,” Badrul Chowdhury, the FDA’s director of the Division of Pulmonary, Allergy, and Rheumatology Products, said in the statement.
Rheumatoid arthritis patients typically start therapy on methotrexate, a generic medicine, before moving to the Humira and J&J drugs. The FDA’s approval would put Xeljanz into direct competition with those drugs, among the top-selling therapies in the U.S., rather than as an option to be used after they fail. Pfizer had said in May that it expected the drug to be used at first mostly in patients who failed the J&J and Abbott products. Humira had $7.9 billion in 2011 sales, Abbott has reported.
U.S. approval was delayed by three months in August, after the company said it would provide the FDA with more analysis of existing data. An agency decision had been scheduled Nov. 21.
The agency approved a 5-milligram dose to be taken twice a day. Pfizer had also sought a 10-milligram dose. The company must conduct two follow-up studies comparing patients on Xeljanz with other available treatments. The FDA didn’t specify which drugs must be included in the studies.
The drug will cost $2,055 for a 30-day supply at wholesale, said Victoria Davis, a Pfizer spokeswoman. She said Pfizer’s drug will cost less than its competitors.
Rheumatoid arthritis is an autoimmune disease in which the body attacks itself. It causes swelling and damage in the joints, which can make basic tasks such as walking or holding items painful. The condition is treated with anti-inflammatory pills like aspirin, or drugs such as Enbrel and Humira that attack the disease directly by modifying the immune system.
About 1.5 million people in the U.S. have the disease, according to the FDA. Early detection can help slow or stop its progression.
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