FDA pushes eczema decision for Eli Lilly's Olumiant, Pfizer's abrocitinib back 3 months — raising more questions for the JAK class
The FDA review extensions for JAK inhibitors are stacking up.
After Eli Lilly and Incyte disclosed late Tuesday that their supplemental NDA for Olumiant in moderate to severe atopic dermatitis was hit with a 3-month delay, Pfizer revealed early Wednesday that its experimental abrocitinib is meeting the same fate. With Olumiant, the agency needed time to “review additional data analyses submitted by Lilly in response to recent information requests from the FDA,” according to a statement. Pfizer didn’t specify a reason in its release.
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