Category: abrocitinib
Pfizer has claimed its first regulatory approval worldwide for Cibinqo, its JAK inhibitor for atopic dermatitis, from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The green light covers England, Scotland Wales, as Northern Ireland remains under the EU regulatory framework, and covers once-daily use of the orally-active drug in adolescents aged over 12 […]
Shots: The head-to-head P-III JADE DARE study involves assessing the efficacy of Abrocitinib (200mg, qd, PO) vs dupilumab (300mg, SC, q2w followed by 600mg induction dose) in adult patients on background topical therapy with moderate to severe AD The study met its co-1EPs of at least a 4-point improvement in the severity of PP-NRS4 @2wks. […]
Shots: The P-lll JADE REGIMEN study involves assessing of Abrocitinib (100/ 200mg) vs PBO in 1233 patients aged ≥ 12 yrs. in a ratio (1:1:1) with mod. to sev. AD following response to initial open-label induction treatment with abrocitinib (200mg) Result: The study met its 1EPs i.e. probability of not experiencing a flare @52wks. (81.1%, […]
Pfizer could be just a few months away from getting FDA approval for its JAK1 inhibitor abrocitinib in atopic dermatitis, a drug that CEO Albert Bourla believes hasn’t been given the credit it is due by Wall Street analysts. The US regulator has started a priority review of abrocitinib for mediate to severe atopic dermatitis […]