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Pfizer Receives the US FDA’s Approval for Cibinqo (abrocitinib) sNDA to Treat Atopic Dermatitis

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Pfizer Receives the US FDA’s Approval for Cibinqo (abrocitinib) sNDA to Treat Atopic Dermatitis

Shots:

  • 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

Related News:- Pfizer’s Cibinqo (abrocitinib) Receives Health Canada Approval for the Treatment of Moderate to Severe Atopic Dermatitis

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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