1 December 2017 - Psoriatic arthritis is the second approved indication for Taltz in the United States.

Eli Lilly announced today that the U.S. FDA has approved Taltz (ixekizumab) injection 80 mg/mL for the treatment of adults with active psoriatic arthritis (PsA). Taltz was first approved by the FDA in March 2016 for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

The efficacy and safety of Taltz was determined from findings from two randomised, double-blind, placebo-controlled Phase 3 studies - SPIRIT-P1 and SPIRIT-P2 - which included more than 670 adult patients with active PsA. SPIRIT-P1 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 anti-rheumatic drug. SPIRIT-P2 evaluated the safety and efficacy of Taltz compared to placebo in tumour necrosis factor inhibitor (TNFi)-experienced patients with active PsA who failed one or two TNF inhibitors. Across both studies, patients were required to have a diagnosis of active PsA for at least six months and at least three tender and three swollen joints. Non-responder imputation methods were used. Inadequate responders (defined by blinded tender and swollen joint count criteria) at Week 16 received rescue therapy and were analysed as non-responders.

Read Eli Lilly press release