Eli Lilly has been given a green light to market Taltz in the European Union as a treatment for psoriatic arthritis.
Taltz (ixekizumab) is an antibody that binds to interleukin-17A, a protein that causes inflammation and plays a role in the development of these conditions.
The drug is administered as an injection, either alone or in combination with a conventional disease-modifying antirheumatic drug such as methotrexate.
Its approval in Europe follows two randomised, double-blind, placebo-controlled Phase III studies - SPIRIT-P1 and SPIRIT-P2 – which included 780 adult patients with the condition.
In SPIRIT-P1, which evaluated the safety and efficacy of Taltz compared to placebo in patients with active PsA who had never been treated with a biologic disease-modifying antirheumatic drug, 58 percent of those treated with the drug achieved an ACR20 response (a 20 percent reduction in a composite measure of disease activity) versus 30 percent for placebo.
In SPIRIT-P2, which pitted Taltz against placebo in tumor necrosis factor inhibitor (TNFi)-experienced patients with active PsA who failed one or two TNF inhibitors, the ACR20 responses were 53 percent and 20 percent, respectively.
On the basis of these results, European regulators have approved the drug’s use, alone or in combination with methotrexate, to treat PsA in adults who have responded inadequately to, or who are intolerant to, one or more disease-modifying anti-rheumatic drug (DMARD) therapies.
“PsA affects up to 30 percent of people who are already living with psoriasis,” said Arash Tahbaz, senior medical director, Eli Lilly and Company UK and Northern Europe.
“Symptoms often begin around a decade after the onset of psoriasis, and can severely impact people’s lives and ability to work. We are proud to be able to offer a new treatment option that addresses both the joint and skin symptoms of PsA.”