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Sotyktu FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 27, 2022.

FDA Approved: Yes (First approved September 9, 2022)
Brand name: Sotyktu
Generic name: deucravacitinib
Dosage form: Tablets
Company: Bristol-Myers Squibb Company
Treatment for: Plaque Psoriasis

Sotyktu (deucravacitinib) is a tyrosine kinase 2 (TYK2) inhibitor indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Development timeline for Sotyktu

DateArticle
Sep 10, 2022Bristol Myers Squibb Announces New Sotyktu™ (deucravacitinib) Long-Term Data Showing Clinical Efficacy Maintained for Up to Two Years with Continuous Treatment in Moderate-to-Severe Plaque Psoriasis
Sep  9, 2022Approval FDA Approves Sotyktu (deucravacitinib) for the Treatment of Adults with Moderate-to-Severe Plaque Psoriasis
Jun  1, 2022Late-Breaking Data at EULAR 2022 Demonstrate Deucravacitinib Significantly Improved Disease Activity in Phase 2 PAISLEY Study in Systemic Lupus Erythematosus
May 12, 2022New Two-Year Deucravacitinib Data Reinforce Durable Efficacy and Consistent Safety Profile in Treatment of Moderate to Severe Plaque Psoriasis
Nov 29, 2021Bristol Myers Squibb’s Applications for Deucravacitinib for the Treatment of Moderate to Severe Plaque Psoriasis Accepted by U.S. Food and Drug Administration and Validated by European Medicines Agency
Oct  7, 2021Bristol Myers Squibb Provides Update on Phase 2 Study of Deucravacitinib in Patients With Moderate to Severe Ulcerative Colitis
Oct  7, 2021Bristol Myers Squibb Provides Update on Phase 2 Study of Deucravacitinib in Patients With Moderate to Severe Ulcerative Colitis
Apr 23, 2021Bristol Myers Squibb Presents Positive Data from Two Pivotal Phase 3 Psoriasis Studies Demonstrating Superiority of Deucravacitinib Compared to Placebo and Otezla® (apremilast)
Feb  2, 2021Bristol Myers Squibb Announces Positive Topline Results from Second Pivotal Phase 3 Psoriasis Study Showing Superiority of Deucravacitinib Compared to Placebo and Otezla (apremilast)
Nov  9, 2020Bristol Myers Squibb Presents Late-Breaking Phase 2 Data Demonstrating the Safety and Efficacy of Deucravacitinib (BMS-986165) in Patients with Psoriatic Arthritis
Nov  3, 2020Bristol Myers Squibb Announces Deucravacitinib (BMS-986165) Demonstrated Superiority to Placebo and Otezla® (apremilast) in Pivotal Phase 3 Psoriasis Study

Further information

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