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CHMP adopts positive opinion for Lilly’s ixekizumab
26 February 2016 • Author: Victoria White
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Lilly’s ixekizumab for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.
Ixekizumab is an IgG4 monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine (<3pM) and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Ixekizumab inhibits the release of pro-inflammatory cytokines and chemokines.
This is the first regulatory step toward approval for ixekizumab in Europe. The CHMP positive opinion is now referred for final action to the European Commission, which grants approval in the EU.
“Psoriasis is a serious, chronic disease that can also have a significant, and sometimes debilitating, psychological and social impact,” said Andrew Hotchkiss, president of Lilly’s European and Canadian operations. “This CHMP positive opinion is a significant milestone in our quest to offer physicians a new treatment option for their patients with moderate-to-severe plaque psoriasis.”
The CHMP positive opinion for ixekizumab was based on findings from the largest Phase 3 trial programme in moderate-to-severe plaque psoriasis evaluated by regulatory authorities to date. This clinical programme included three double-blind, multicentre, Phase 3 studies—UNCOVER-1, UNCOVER-2 and UNCOVER-3—which demonstrated the safety and efficacy of ixekizumab in more than 3,800 patients in 21 countries with moderate-to-severe plaque psoriasis. All three studies evaluated the safety and efficacy of ixekizumab (80 mg every two weeks, following a 160-mg starting dose) compared to placebo after 12 weeks. UNCOVER-2 and UNCOVER-3 included an additional comparator arm in which patients received etanercept (50 mg twice a week) for 12 weeks.
In these studies, the co-primary efficacy endpoints at 12 weeks were Psoriasis Area Severity Index (PASI) 75 and static Physician’s Global Assessment (sPGA) 0 or 1.
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