Eli Lilly and Company announced that ixekizumab [TALTZ®] has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the treatment of moderate-to-severe plaque psoriasis in adults in the European Union (EU) who are candidates for systemic therapy,1 Ixekizumab is specifically designed to target the cytokine interleukin IL-17A, a protein that plays a key role in driving underlying inflammation in psoriasis.2
Eli Lilly and Company announced that ixekizumab [TALTZ®] has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the treatment of moderate-to-severe plaque psoriasis in adults in the European Union (EU) who are candidates for systemic therapy,1 Ixekizumab is specifically designed to target the cytokine interleukin IL-17A, a protein that plays a key role in driving underlying inflammation in psoriasis.2
“Psoriasis is a serious, chronic disease that can also have a significant, and sometimes debilitating, psychological and social impact,” said Andrew Hotchkiss, President for Lilly Bio-Medicines in Europe and Canada. “This CHMP positive opinion is a significant milestone in our quest to offer physicians a new therapeutic option for their patients with moderate-to-severe plaque psoriasis.”
The CHMP opinion is based on data from seven clinical trials, including three double-blinded multicentre Phase III studies – UNCOVER-1, UNCOVER-2 and UNCOVER-3 – which demonstrate the safety and efficacy of ixekizumab in more than 3800 patients in 21 countries with moderate-to-severe plaque psoriasis.3,4
This is the first regulatory step towards approval for ixekizumab in Europe. The CHMP positive opinion is now referred to the European Commission, which has the authority to approve medicines for the EU. We expect a final decision on marketing authorisation within three months.
References:
- CHMP opinion issued 25.02.16 http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/003943/WC500202360.pdf. Accessed February 26 2016.
- Krueger J et al. IL-17A is essential for cell activation and inflammatory gene circuits in subjects with psoriasis. J Allergy Clin Immunol 2012;130(1):145–154.e9.
- Griffiths C et al. Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials. Lancet 2015;386(9993):541–51.
- A Phase 3 Study in Participants With Moderate to Severe Psoriasis (UNCOVER-1). https://clinicaltrials.gov/ct2/show/NCT01474512?term=NCT01474512&rank=1. Accessed 15 February 2016.
