Posted by Michael Wonder on 22 May 2018
Lilly's Taltz (ixekizumab) receives the first U.S. FDA approval for label update to include data for psoriasis involving the genital area
22 May 2018 - The label update is effective immediately in the United States.
Eli Lilly announced today that the U.S. FDA has approved a label update for Taltz (ixekizumab) injection 80 mg/mL to include data in psoriasis involving the genital area. Taltz is the first and only treatment approved by the FDA for moderate-to-severe plaque psoriasis that includes such data in its label. 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. In December 2017, Taltz was also approved for the treatment of adults with active psoriatic arthritis.
The label update is based on positive results from the first randomized, double-blind, placebo-controlled study in moderate-to-severe psoriasis involving the genital area.
