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Eucrisa Approval History

Reviewed on Dec 14, 2016 by J.Stewart BPharm
  • FDA approved: Yes (First approved December 14th, 2016)
  • Brand name: Eucrisa
  • Generic name: crisaborole
  • Dosage form: Topical Ointment
  • Company: Pfizer Inc.
  • Treatment for: Atopic Dermatitis

Eucrisa (crisaborole) is a novel, non-steroidal topical anti-inflammatory phosphodiesterase-4 (PDE-4) inhibitor indicated for the treatment of mild-to-moderate atopic dermatitis.

The approval of Eucrisa was based the results of two large clinical trials (Trials 1 and 2) that treated 1,522 patients with mild to moderate atopic dermatitis. In both trials, patients were randomized to receive Eucrisa or vehicle (non-medicated ointment) twice daily for 28 days. Data showed Eucrisa to be an effective treatment that achieved statistically significant results, with a greater number of patients reporting clear or almost clear skin at the end of the trial period, with some achieving success as early as day eight.

Eucrisa is applied as a thin layer to the affected areas twice daily. Common side effects include pain at the application site, such as burning or stinging.

Development History and FDA Approval Process for Eucrisa

DateArticle
Dec 14, 2016Approval FDA Approves Eucrisa (crisaborole) for Eczema
Jul 13, 2016Pfizer Announces the Publication of Final Results from Two Pivotal Phase 3 Studies of Crisaborole Topical Ointment in Patients with Mild to Moderate Atopic Dermatitis
Mar 22, 2016Anacor Pharmaceuticals Announces FDA Acceptance of NDA for Crisaborole Topical Ointment, 2% for the Treatment of Mild-to-Moderate Atopic Dermatitis
Jan  7, 2016Anacor Pharmaceuticals Submits NDA to the FDA for Crisaborole Topical Ointment, 2% for the Treatment of Mild-to-Moderate Atopic Dermatitis

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