Lilly’s psoriasis therapy ixekizumab has been recommended for EU approval by the Europe’s Committee for Medicinal Products for Human Use (CHMP).
A positive opinion for ixekizumab has been issued by the European Medicines Agency committee for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.
The recommendation was based on findings from the phase III trial programme in moderate-to-severe plaque psoriasis. The trial is the largest to date to be evaluated by regulatory authorities.
IL-17A, a protein that plays a key role in driving underlying inflammation in psoriasis, is specifically targeted by ixekizumab.
A final decision on marketing authorisation of the drug is expected to be confirmed within three months.
Andrew Hotchkiss, president of Lilly’s European and Canadian operations, said: “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.”