FDA Advisers Back Pfizer Inc. Arthritis Drug
Published: May 11, 2012
A federal advisory panel recommended approval on Wednesday of a rheumatoid arthritis pill that could offer patients an alternative to the injectable medicines already on the market, but several members expressed concern about safety and urged the Food and Drug Administration to require rigorous follow-up studies. The arthritis advisory committee voted 8 to 2 that the drug, known as tofacitinib, offered enough benefits to overcome potential safety risks, including higher rates of lymphoma and other cancers and serious infections. The agency, which is scheduled to decide on approval by August, usually — but not always — follows the advice of advisory committees.