Ixekizumab (Taltz ) for Plaque Psoriasis Clears FDA

Megan Brooks

March 22, 2016

The US Food and Drug Administration (FDA) has approved ixekizumab (Taltz, Eli Lilly) to treat adults with moderate-to-severe plaque psoriasis.

Ixekizumab is a humanized monoclonal antibody that targets interleukin 17A, which drives inflammation in psoriasis. Ixekizumab is administered as an injection and is intended for patients who are candidates for systemic therapy, phototherapy, or a combination of both.

"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," Julie Beitz, MD, director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research, said in a news release.

The safety and efficacy of ixekizumab were demonstrated in three randomized, placebo-controlled trials involving more than 3800 patients with plaque psoriasis eligible for ixekizumab.

The results showed that 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," the FDA said in the release.

Because ixekizumab is an immunotherapy, it is being approved with a Medication Guide to inform patients that they may have a greater risk for an infection, or an allergic or autoimmune condition, the agency notes.

The most common side effects include upper respiratory infections, injection-site reactions and fungal (tinea) infections. Serious allergic reactions and development or worsening of inflammatory bowel disease have been reported with ixekizumab and patients should be monitored "closely" for these conditions, the FDA said.

Last month, the European Medicines Agency's Committee for Medicinal Products for Human Use recommended the marketing of ixekizumab for treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.

Psoriasis affects about 125 million people worldwide, roughly 20% of whom have moderate-to-severe plaque psoriasis, according to Eli Lilly.


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