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Taltz Approval History

Taltz (ixekizumab) is a humanized interleukin-17A antagonist indicated for the treatment of adults with moderate-to-severe plaque psoriasis.

The FDA approval of Taltz was based on findings from the UNCOVER-1, UNCOVER-2 and UNCOVER-3 Phase 3 trials that included more than 3,800 patients with moderate-to-severe plaque psoriasis. In all three studies, 87 to 90 percent of patients treated with Taltz saw a significant improvement in their condition at 12 weeks.

Taltz is administered via subcutaneous injection every two weeks for the first 12 weeks, and then every four weeks. The most common side effects reported during clinical trials were injection site reactions, upper respiratory tract infections, nausea, and fungal skin infections.

Development History and FDA Approval Process for Taltz

DateArticle
Mar 22, 2016Approval FDA Approves Taltz (ixekizumab) for Plaque Psoriasis
Mar  4, 2016Ixekizumab Demonstrates Rapid, Clinically Meaningful Improvements As Early As One Week Among Patients With Moderate-To-Severe Plaque Psoriasis
Nov  8, 2015Patients Show Significant Improvement In Signs And Symptoms Of Psoriatic Arthritis, Less Progression Of Structural Joint Damage When Treated With Ixekizumab For 24 Weeks
Jun 10, 2015Studies Show Psoriasis Patients Achieved Significant Levels Of Skin Clearance And Improved Quality Of Life After 12 Weeks Of Ixekizumab Treatment
Aug 21, 2014Lilly's Ixekizumab Superior to Etanercept and Placebo in Phase 3 Psoriasis Studies

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