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U.S. FDA Advisers Back Pfizer Inc Arthritis Drug-Reuters


Wednesday, 9 May 2012 04:11pm EDT 

Reuters reported that Pfizer Inc won support from a U.S. advisory panel on Wednesday for its arthritis drug. A panel of outside experts to the U.S. Food and Drug Administration voted 8-2 to recommend approval of tofacitinib, a treatment for patients with rheumatoid arthritis who have not had success with at least one other drug for the disease. The FDA usually follows panel recommendations, although it is not required to do so, and a final decision is expected in August. "I think the data for efficacy is compelling and it’s at least as good as other biologic agents," said Dr. Maria Suarez-Almazor, panel member and section chief in rheumatology at MD Anderson Cancer Center in Houston. However, most panelists said the drug should only be used once patients had tried at least several other drugs for the disease, not just one. They expressed concern about some of its side effects, such as infections and malignancies, or cancerous cells that can spread. In a review earlier this week, FDA staff said tofacitinib may have a higher risk of serious infections such as pneumonia and a possible link to malignancies, which may get worse with higher doses or longer exposure to the drug. Panelists called on Pfizer to study the drug's safety post-approval.[ID:nL1E8G73ML] Most analysts said the panel's vote meant the drug was likely to be approved, although doctors were unlikely to prescribe it to patients unless they had tried several other options, limiting initial sales. 

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