FDA panel backs tofacitinib for RA

FDA's Arthritis Advisory Committee voted 8-2 in favor of recommending approval of tofacitinib from Pfizer Inc. (NYSE:PFE) to treat moderately to severely active rheumatoid arthritis (RA) in patients who have had inadequate response to one or more 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 one 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.

The committee voted 8-2 that the data did not provide substantial evidence of the efficacy for radiographic outcomes. Most panelists said the compound likely provides a beneficial effect on reducing structural damage, but that the small degree of progression seen in the placebo group made it difficult to see a significant treatment effect. In the primary analysis, the 10 mg dose showed a statistically significant change from baseline compared with placebo on the radiographic modified total Sharp Score (mTSS) (p=0.0376) at six months. The 5 mg dose was not significantly different (p=0.0792). ...