March 23, 2016

FDA Approves Ixekizumab for Adults With Plaque Psoriasis

ROCKVILLE, Md -- March 23, 2016 -- The US Food and Drug Administration (FDA) has approved ixekizumab (Taltz) for the treatment of adults with moderate-to-severe plaque psoriasis.

“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,” said Julie Beitz, MD, FDA’s Center for Drug Evaluation and Research, Rockville, Maryland.

Ixekizumab binds to a protein (interleukin [IL]-17A) that causes inflammation. By binding to the protein, ixekizumab is able to inhibit the inflammatory response that plays a role in the development of plaque psoriasis.

Taltz is administered as an injection. It is intended for patients who are candidates for systemic therapy, phototherapy, or a combination of both.

The safety and efficacy ixekizumab were established in 3 randomised, placebo-controlled clinical trials comprising 3,866 participants with plaque psoriasis who were candidates for systemic or phototherapy therapy. The results showed that patients receiving ixekizumab 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.

Because ixekizumab is a medicine that affects the immune system, it is being approved with a Medication Guide to inform patients that they may have a greater risk of an infection, or an allergic or autoimmune condition. Serious allergic reactions and development or worsening of inflammatory bowel disease have been reported with the use of ixekizumab. Physicians should monitor patients closely for these conditions.

The most common side effects associated with use of ixekizumab included upper respiratory infections, injection site reactions, and fungal infections.

SOURCE: US Food and Drug Administration

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