FDA Greenlights Taltz for Psoriasis

03/21/2016

The U.S. Food and Drug Administration approved the IL-17A blocker Taltz (ixekizumab) for adults with moderate-to-severe plaque psoriasis.

Taltz is marketed by Indianapolis, Indiana-based Eli Lilly and Company. Given via 80 mg/mL injection, Taltz’s active ingredient is an antibody (ixekizumab) that binds to a protein (interleukin (IL)-17A) that causes inflammation. It is intended for patients who are candidates for systemic therapy, phototherapy or a combination of both. 

Taltz’s safety and efficacy 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. The results showed that Taltz achieved greater clinical response than placebo, with skin that was clear or almost clear, as assessed by scoring of the extent, nature and severity of psoriatic changes of the skin.

Taltz is being approved with a Medication Guide to inform patients about risk of infection or allergic or autoimmune condition. Serious allergic reactions and development or worsening of inflammatory bowel disease have been reported with the use of Taltz. The most common side effects include upper respiratory infections, injection site reactions and fungal (tinea) infections.

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