Pfizer Receives the US FDA’s Approval for Cibinqo (abrocitinib) sNDA to Treat Atopic Dermatitis
- The US FDA has approved its sNDA for Cibinqo to include adolescents aged 12-<18yrs. with refractory, mod. to sev. AD
- The approval was based on prior studies' results incl. 124 adolescent patients and a P-III study (JADE TEEN) evaluating abrocitinib (100/200mg, qd) vs PBO in 285 patients for 12wks. The (JADE TEEN) trial results showed that 39% & 46% vs 24% achieved an IGA 0 or 1 response, EASI-75 response (64% & 71% vs 41%) @12wk., a 4-point decrease from baseline in PP-NRS score @2wk. (13% & 25% vs 8%), respectively. The safety profile was consistent with the pivotal trials
- Cibinqo has received marketing authorization in the US, EU, Great Britain & other countries & has launched in Germany, Japan, China & ≥20 other markets globally
Ref: Businessnewswire | Image: Pfizer
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