Taltz Approval History
- FDA approved: Yes (First approved March 22nd, 2016)
- Brand name: Taltz
- Generic name: ixekizumab
- Dosage form: Injection
- Company: Eli Lilly and Company
- Treatment for: Plaque Psoriasis
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
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