Abrocitinib priority review for atopic dermatitis extended
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The FDA has extended the priority review period for abrocitinib’s New Drug Application for the treatment of moderate to severe atopic dermatitis, Pfizer announced in a press release.
A phase 3 trial of abrocitinib, an oral small molecule (JAK) 1 , found both 100 and 200 mg doses of the drug significantly improved atopic dermatitis signs and symptoms after 12 weeks of treatment.
The Prescription Drug User Fee Act (PDUFA) goal date has been extended months to early in the third quarter of 2021, according to the release.
In addition, the Supplemental New Drug Application review period for Pfizer’s Xeljanz (tofacitinib) for the treatment of active ankylosing spondylitis has been extended by months.
Xeljanz has been approved by the FDA for the treatment of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and polyarticular course juvenile idiopathic arthritis.
The new sNDA goal date will also be in early Q3.
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