Therapy Areas: Inflammatory Diseases
EU Grants Marketing Authorisation to Lilly for Taltz (ixekizumab) for Treatment of Certain Patients with Active Psoriatic Arthritis
29 January 2018 - - Indianapolis, Indiana-based global pharmaceuticals specialist Eli Lilly and Company (NYSE: LLY) has been granted marketing authorisation by the European Commission for Taltz (ixekizumab), alone or in combination with methotrexate, for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying anti-rheumatic drug (DMARD) therapies, the company said.
This is the second approved indication for ixekizumab in the EU; it was authorized for the treatment of adult patients with moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy in Europe in April 2016.
Ixekizumab is an IgG4 monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine 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.
The European Commission Marketing Authorisation for ixekizumab in PsA was based on findings from a Phase 3 clinical trial programme.
The efficacy and safety of ixekizumab was determined from findings from two randomized, double-blind, placebo-controlled Phase 3 studies, SPIRIT-P1 and SPIRIT-P2 which included 780 adult patients with active PsA.
In both studies, patients treated with ixekizumab achieved significant improvement in joint symptoms and skin symptoms compared with placebo.
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