Tofacitinib regulatory update

FDA's Arthritis Advisory Committee voted 8-2 in favor of recommending approval of tofacitinib from Pfizer to treat moderately to severely active rheumatoid arthritis in patients who have had inadequate response to >=1 DMARDs. Panelists also voted 10-0 that the oral pan-Janus kinase (JAK) inhibitor showed substantial evidence of efficacy to support approval and 7-2, with 1 abstention, that the product had an adequate safety profile. Committee members said they felt more comfortable with the 5 mg dose over the 10 mg dose of tofacitinib because of a risk of serious infections, malignancies and liver test abnormalities. ...