Ixekizumab is approved to treat moderate to severe plaque psoriasis in adults, according to an announcement from the Food and Drug Administration.
“Today’s approval provides patients suffering from plaque psoriasis with another important treatment option to help relieve the skin irritation and discomfort from the condition,” Dr. Julie Beitz, director of the FDA’s Office of Drug Evaluation III, said in a statement .
Ixekizumab is an IgG4 monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokines, inhibiting interaction with the IL-17 receptor. It is approved for patients who are candidates for systemic therapy, phototherapy, or a combination of both.
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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 therapy or phototherapy. Patients treated with ixekizumab achieved greater clinical response than did those who received placebo.
The therapy was approved with a medication guide to inform patients that they may have a greater risk of an infection, or an allergic or autoimmune condition, according to the FDA announcement. The agency advised that physicians should monitor patient for serious allergic reactions and development or worsening of inflammatory bowel disease.
The most common adverse events seen in clinical trials of ixekizumab were upper respiratory infections, injection site reactions, and tinea.
Ixekizumab will be marketed as Taltz by Eli Lilly and Company.
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