Research & Development
Lilly awarded FDA approval for Taltz to treat paediatric patients with moderate to severe plaque psoriasis
31 March 2020 -

Health care company Eli Lilly and Company (NYSE:LLY) revealed on Monday that the US Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for Taltz injection in 80 mg/ml for the treatment of paediatric patients with moderate to severe plaque psoriasis.

The US FDA has approved the sBLA for the company's Taltz (ixekizumab) injection in 80 mg/ml for the treatment of paediatric patients (ages six to under 18) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

In conjunction, the safety, tolerability and efficacy of Taltz in patients ages six to under 18 was demonstrated in the company's randomized, double-blind, placebo-controlled Phase 3 study that included 171 patients with moderate to severe plaque psoriasis. The patients were randomized to receive Taltz (20 mg for 50 kg through Week 12, with 40 mg, 80 mg or 160 mg starting doses, respectively) or placebo. Taltz met all major secondary endpoints in the study.

According to the company, Taltz (ixekizumab) is a 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. Taltz inhibits the release of pro-inflammatory cytokines and chemokines and is the first and only IL-17A antagonist approved for paediatric patients with severe plaque psoriasis

Following the US FDA approval, the company will work with insurers, health systems and providers to ensure patients are able to access the treatment.

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