Pfizer’s Xeljanz denied plaque psoriasis indication by FDA
pharmafile | October 16, 2015 | News story | Research and Development, Sales and Marketing | FDA, Pfizer, Xeljanj, tofacitinib
The FDA has rejected the indication expansion of Pfizer’s Xeljanz (tofacitinib) for treatment of moderate to severe cases of plaque psoriasis.
The New York drugmaker received a complete response letter with recommendations for its psoriasis supplemental New Drug Application (sNDA), on which Pfizer said it will work closely with regulators to address their comments on the filing.
Kenneth Verburg, senior vice president and head of global medicines development, Global Innovative Pharma Business, says: “Pfizer remains committed to Xeljanz based on the strength of the clinical data for the treatment of psoriasis.” He adds: “It is our goal to work closely with the FDA to understand and address their comments about our filing for the use of Xeljanz in patients with chronic plaque psoriasis.”
Pfizer had hoped to see the FDA open the door for Xeljanz in more than a million new patients.
According to Pfizer, plaque psoriasis affects about 7.4 million people in the US, and 20% of those patients have moderate to severe forms of the condition. A new indication would have helped Xeljanz build on the $224 million sales tally it racked up through the first six months of this year but does not quite match numbers industry-watchers once predicted.
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’s 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. At the five milligram dose, Enbrel beat out Pfizer’s drug, whilst researchers still observed serious side effects.
However, all hope is not lost for a label expansion as last month, as Pfizer reported positive data from a pair of trials evaluating the med in ulcerative colitis. 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.
Yasmita Kumar
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