FDA Turns Down Pfizer’s Bid to Market Rheumatoid Arthritis Drug

The FDA has turned down Pfizer’s bid to market its rheumatoid arthritis drug Xeljanz for psoriasis patients.

The company said last week that the FDA’s complete response letter asks for more analyses of Xeljanz’s (tofacitinib) safety in treating patients with moderate to severe chronic plaque psoriasis. Pfizer declined to provide other specifics about letter, saying that clinical results for the indication have been strong.

If approved, the medication could be a boon for the more than 1 million patients suffering from CPP in the U.S. and challenge AbbVie’s Humira (adalimumab), which raked in $12.5 billion last year.

Xeljanz, an oral Janus kinase inhibitor, was approved in the U.S. in 2012 to treat moderate to severe rheumatoid arthritis. The company is studying other potential indications and reported promising results last month in an ulcerative colitis trial. — Victoria Pelham