Lilly's ixekizumab (Taltz) granted EC marketing authorisation for treatment of plaque psoriasis

Eli Lilly and Company announced today that the European Commission has granted marketing authorisation for ixekizumab (Taltz) for the treatment of moderate-to-severe plaque psoriasis in adults in the European Union (EU) who are candidates for systemic therapy. Ixekizumab is specifically designed to target the cytokine interleukin IL-17A, a protein that plays a role in driving underlying inflammation in psoriasis.

“Psoriasis can have a profound, detrimental impact on a person’s quality of life,” said Professor Christopher Griffiths, Foundation Professor of Dermatology, University of Manchester. “As such, the authorisation of ixekizumab will offer a new biological treatment option for patients with moderate-to-severe plaque psoriasis.”

“Psoriasis is a serious, chronic disease, associated with significant comorbidities including heart disease. There is currently no cure for psoriasis,” said Andrew Hotchkiss, president of Lilly’s European and Canadian operations. “Lilly is excited to make ixekizumab available in the European Union for physicians looking to provide a new treatment option for patients with moderate-to-severe plaque psoriasis.”

The marketing authorisation of ixekizumab is based on data from seven clinical trials, including three pivotal double-blinded multicentre Phase III studies – UNCOVER-1, UNCOVER-2 and UNCOVER-3 – which evaluated more than 3,800 patients with moderate-to-severe plaque psoriasis from 21 countries.iii This number includes patients who began the trial on ixekizumab or placebo, or active comparator (etanercept). The very common (≥1/10 patients)adverse events in clinical trials were injection site reactions and upper respiratory tract infections (most frequently nasopharyngitis).