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FDA Approves New Treatment for Plaque Psoriasis


March 23, 2016

The FDA has approved Taltz (ixekizumab, Eli Lilly and Company) for the treatment of moderate-to-severe plaque psoriasis in adults. Ixekizumab is administered as an injection and is indicated for patients who are candidates for systemic therapy, phototherapy, or a combination of both. 

Safety and efficacy of ixekizumab were demonstrated in 3 randomized, placebo-controlled trials involving more than 3800 people with plaque psoriasis who were candidates for systemic therapy or phototherapy. Ixekizumab achieved a greater clinical response than placebo and resulted in clear or almost clear skin, as assessed by scoring of the extent, nature, and severity of psoriatic changes of the skin. The drug was also superior to Enbrel (etanercept, Amgen Inc) on all measures of skin clearance. 

Ixekizumab binds to the inflammatory protein interleukin-17A, hindering the inflammatory response that plays a role in the development of plaque psoriasis. Because ixekizumab is an immunotherapy, it was approved with a Medication Guide to inform patients of the risks associated with the treatment. Patients taking ixekizumab may be at a greater risk of infection or of developing an allergic or autoimmune condition.

Ixekizumab is expected to be one of Lilly's top drug prospects, with an anticipated marketshare of more than $1 billion per year by 2020. The company plans to launch ixekizumab in the United States in the second quarter of this year.  

Ixekizumab is currently approved in Europe. 

 

Reference

FDA approves new psoriasis drug Taltz. FDA. March 22, 2016.

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