The FDA has asked for an additional three months to review Pfizer’s experimental atopic dermatitis drug.
This week, the company said that the extended review will push back an approval decision to Q3 of this year. Pfizer didn’t disclose the exact reason for the delay, but the drug, abrocitinib, belongs to a new class of medicines called JAK inhibitors that have been clouded by safety concerns.
Last year, the FDA rejected a JAK inhibitor tested for rheumatoid arthritis from Gilead called filgotinib over toxicity concerns.
In addition to the abrocitinib setback, Pfizer said the FDA has also delayed an expanded indication decision on Xeljanx, another JAK inhibitor that’s already been approved for several inflammation-related conditions, for spondylitis. Trials of the drug have linked it to increased risk of heart issues and cancer. Canada’s health regulator, meanwhile, said it is also launching a new investigation into the safety of Xeljanx given the rising concerns around the drug.
Read the Reuters report.
