CHMP Backs Ixekizumab (Taltz) for Plaque Psoriasis

Megan Brooks


February 26, 2016

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of ixekizumab (Taltz, Eli Lilly) for treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.

Ixekizumab is a humanized monoclonal antibody that targets interleukin 17A (IL-17), which drives inflammation in psoriasis.

The CHMP recommendation is based on data from three double-blinded, multicenter, phase 3 studies, which demonstrated the safety and efficacy of ixekizumab in more than 3800 patients in 21 countries who had moderate-to-severe plaque psoriasis.

All three studies evaluated the safety and efficacy of ixekizumab (80 mg every 2 weeks, after a 160-mg starting dose) compared with placebo after 12 weeks. Two of the studies included an additional comparator group in which patients received etanercept (50 mg twice a week) for 12 weeks.

Ixekizumab showed "statistically significant and clinically relevant effects" compared with placebo or etanercept in terms of Psoriasis Area and Severity Index score 75 and static Physician Global Assessment of 0 or 1 (sPGA 0/1) at week 12, the European Medicines Agency notes in a statement.

PASI 90, PASI 100, and sPGA 0 response rates indicating nearly complete/complete clearance were also statistically significantly better with ixekizumab compared with placebo or etanercept, the agency notes.

The most common adverse drug reactions in testing were mild or moderate upper respiratory tract infections. The CHMP said ixekizumab should be prescribed by physicians experienced in the treatment and diagnosis of psoriasis.

Detailed recommendations for the use of ixekizumab will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after marketing authorization has been granted by the European Commission.

Eli Lilly said it expects a final decision on marketing authorization within the next 3 months. Ixekizumab will be available as an 80-mg solution for injection.

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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