The FDA announced Tuesday that it approved Eli Lilly's monoclonal antibody Taltz (ixekizumab) targeting IL-17A to treat adults with moderate-to-severe plaque psoriasis. Julie Beitz, director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research, said the decision "provides patients suffering from plaque psoriasis with another important treatment option to help relieve the skin irritation and discomfort from the condition."
According to the FDA, the safety and efficacy of the injectable drug were established in the Phase III UNCOVER studies involving a total of 3866 patients with plaque psoriasis who were suitable for systemic therapy or phototherapy. Specifically, data from the trials released in 2014 showed that Taltz was "statistically superior" to Amgen's Enbrel (etanercept) and placebo in all skin measures in patients with moderate-to-severe plaque psoriasis.
Last month, the European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion for Taltz in the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.
To read more Top Story articles, click here.