Eli Lilly and Co. received the U.S. Food and Drug Administration's approval to update the prescription label of its psoriasis treatment, Taltz injection, to include data in psoriasis involving the genital area.
Psoriasis is an inflammatory, autoimmune condition characterized by patches of abnormal skin in the body.
Taltz is the first and only treatment approved by the FDA to treat adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy as well as active psoriatic arthritis, a chronic autoimmune disease characterized by inflammation of the skin and joints.
The updated label will include data from a study that evaluated the drug versus placebo among 149 patients with moderate-to-severe psoriasis involving the genital area, who were candidates for phototherapy or systemic therapy and were unresponsive or intolerant of at least one topical therapy.
At 12 weeks, patients who were treated with Taltz experienced significant improvements in the severity of psoriasis affecting their genital area compared to placebo.
