Ixekizumab, sold under the brand name Taltz, is an injectable medication for the treatment of autoimmune diseases.
[12] The drug was developed by Eli Lilly and Co. and is approved for the treatment of plaque psoriasis in the European Union and the United States as of 2016.
[14] In the European Union it is indicated for the treatment of moderate-to-severe plaque psoriasis[6] and as a second-line therapy for active psoriatic arthritis.
Until the 60th study week, 11–44% of ixekizumab treated patients relapsed (again, depending on the dosing scheme), as compared to 84% under placebo.
In the hinge region, a serine is replaced by a proline to reduce formation of half-antibodies and heterodimers in the manufacturing process.
[22][full citation needed] Ixekizumab was approved by the US Food and Drug Administration (FDA) in March 2016, for the treatment of adults with moderate-to-severe plaque psoriasis[12] and by the European Medicines Agency (EMA) in April 2016.
[6] The safety and efficacy of ixekizumab were established in three randomized, placebo-controlled clinical trials with a total of 3,866 participants with plaque psoriasis who were candidates for systemic or phototherapy therapy.
[12] The FDA approved ixekizumab based on the evidence from three clinical trials of 1958 participants with moderate to severe psoriasis.
[23] The trials were conducted in the US, Canada, Europe, Russia, Mexico, Chile, Argentina, Japan and Australia.