FDA Expands Approval of Injectable Psoriasis Drug

12/04/17

The FDA has approved ixekizumab (Taltz) injection 80 mg/mL for the treatment of adults with psoriatic arthritis (PsA).

The drug was first approved in March 2016 for the treatment of adults with moderate-to-severe plaque psoriasis who were candidates for systemic therapy of phototherapy. It can be administered alone or in combination with conventional disease-modifying antirheumatic drugs, such as methotrexate.

Ixekizumab’s safety and efficacy were determined in 2 randomized, double-blind, placebo-controlled Phase 3 studies (SPIRIT-P1 and SPIRIT-P2). In SPIRIT-P1, ixekizumab was compared with placebo in patients with active PsA who had never been treated with a  biologic disease-modifying antirheumatic drug. In SPIRIT-P2, ixekizumab was compared with placebo in tumor necrosis factor (TNF) inhibitor-experienced patients with active PsA who failed to respond to 1 or 2 TNF inhibitors.

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Study results demonstrated that those patients treated with ixekizumab achieved significant improvement in joint symptoms, as measured by ACR20, compared with placebo.—Michael Potts