Pfizer Inc.’s Janus kinase inhibitor tofacitinib should be approved for rheumatoid arthritis patients, but in a narrower second-line indication than that proposed by the sponsor, an 8-2 majority of FDA’s Arthritis Advisory Committee said May 9.
The sponsor-proposed indication would allow any adult patient with moderately to severely active rheumatoid arthritis who has had an inadequate response to one or more disease-modifying anti-rheumatic drugs take tofacitinib. But this is too broad given the safety concerns with the drug, several committee members said
