The Food and Drug Administration (FDA) has approved the IL-17 inhibitor, Taltz® (ixekizumab) for use in adults with moderate to severe plaque psoriasis. Taltz is an antibody that binds interleukin (IL)-17A. Its safety and effectiveness were established in three large, comparative, placebo-controlled clinical trials that involved 3,866 participants with plaque psoriasis who were candidates for systemic therapy or phototherapy.
The results of these 3 pivotal studies (UNCOVER 1-3) demonstrated that Taltz achieved superior clinical responses compared to placebo. In all three studies, at 12 weeks, 87-90% of patients treated with Taltz saw a significant improvement in their plaque psoriasis. Importantly, 35-42% of individuals treated with Taltz experienced a complete resolution of their psoriasis plaque. Taltz was generally well tolerated and the most common side effects were upper respiratory infections, injection site reactions and fungal infections of the skin.
Taltz will be available in the second quarter of 2016 and is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Taltz is the second IL-17 inhibitor to receive approval for the treatment of psoriasis. The other (Cosentyx or secukinumab) was approved late last year for the same indication.
Taltz is marketed by Eli Lilly and Company.
Reference: FDA news release. Retrieved March 23, 2016, from FDA approves new psoriasis drug Taltz