FDA Advisory Committee Backs New Indication for Pfizer’s Xeljanz

An FDA advisory committee voted 10-to-1 Thursday to recommend approval of Pfizer’s Xeljanz (tofacitinib) for treatment of psoriatic arthritis.

The agency’s Arthritis Advisory Committee also held separate votes on the drug’s safety and efficacy — voting 10-to-1 two more times for approval. Xeljanz was first approved in 2012 for treating rheumatoid arthritis.

Clinical trials reported four deaths, with three linked to cardiovascular causes and one due to an unrelated case of pancreatic cancer, according to Pfizer representatives. The trials suggested an associated risk of herpes zoster, but the sponsor noted that the safety profile in the psoriatic arthritis program was consistent with those observed in the rheumatoid arthritis database.