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Spevigo FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 7, 2022.

FDA Approved: Yes (First approved September 1, 2022)
Brand name: Spevigo
Generic name: spesolimab-sbzo
Dosage form: Injection
Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Treatment for: Generalized Pustular Psoriasis

Spevigo (spesolimab-sbzo) is an interleukin-36 receptor antagonist indicated for the treatment of generalized pustular psoriasis flares in adults.

Development timeline for Spevigo

Sep  3, 2022Approval FDA Approves Spevigo (spesolimab-sbzo) for Generalized Pustular Psoriasis (GPP) Flares in Adults
Mar 28, 2022New Spesolimab Data Showed Significant Improvement in Patients with Generalized Pustular Psoriasis (GPP) Flares
Dec 23, 2021Newly Published Results Showed Spesolimab Significantly Improved Signs and Symptoms of Flares in Rare, Life-Threatening Skin Disease, Generalized Pustular Psoriasis
Dec 15, 2021U.S. FDA Grants Priority Review for Spesolimab for the Treatment of Flares in Patients with Generalized Pustular Psoriasis (GPP)

Further information

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