Pfizer (NYSE:PFE) has announced that the FDA has approved its supplemental New Drug Application (sNDA) for Cibinqo (abrocitinib) for moderate-to-severe atopic dermatitis. The approval expands the indication for the drug, which was previously only approved for adults with the skin condition in early 2022.
The expanded indication includes adolescents between the ages of 12 and 18 whose disease is not adequately controlled with other systemic drugs or when their use is inadvisable.
Cibinqo is a potential blockbusterIn 2020, Pfizer had estimated that abrocitinib would eventually garner $3 billion in peak annual sales.
The company is also investigating its potential in prurigo nodularis and pruritus.
The systemic JAK inhibitor is in the same class as baricitinib from Incyte and Lilly and upadacitinib from AbbVie.
The FDA updated the prescribing information for Cibinqo to include data from the JADE TEEN clinical trial, which evaluated the 100 mg…