Pfizer ($PFE) will have to keep waiting on its hopes for Xeljanz (tofacitinib) expansion. For now, the FDA has turned down the slow-starting med as a treatment for moderate to severe cases of plaque psoriasis.
Wednesday, the agency handed the New York drugmaker a complete response letter with recommendations for its psoriasis sNDA, and Pfizer intends to work closely with regulators to address their comments on the filing, Kenneth Verburg, Pfizer SVP and head of global medicines, said in a statement. That'll include providing additional safety info on the drug, the company said.
Pfizer had hoped to see the FDA open the door for Xeljanz in more than a million new patients; plaque psoriasis affects about 5.9 million people in the U.S., according to the pharma giant, and 20% of those patients have moderate to severe forms of the condition. And a new indication would have helped Xeljanz build on the $224 million sales tally it racked up through the first 6 months of this year--one that doesn't quite measure up to the blockbuster numbers industry-watchers once predicted.
But back in 2013, the drug posted mixed trial results in psoriasis that suggested it might face a rocky regulatory road. In a late-stage study, a high 10-milligram dose of Xeljanz proved as effective as Amgen ($AMGN) giant Enbrel at treating adults with psoriasis, but concerns over elevated safety risks prevented it from winning approval at that dose in its original indication for rheumatoid arthritis. And at the 5-milligram dose, Enbrel beat out the Pfizer drug, and researchers still observed serious side effects.
"Based on our doctor checks, the safety of tofacitinib is not clean enough to garner broad use by the risk-averse dermatology community," Citi analyst Yaron Werber wrote in a research report at the time.
That doesn't mean all hopes for a label expansion are lost. Last month, Pfizer reported positive data from a pair of trials evaluating the med in ulcerative colitis. And those studies are part of a group of four expected to form a potential regulatory submission package for a nod in UC, a chronic condition that affects millions of people around the world.
- read Pfizer's release
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