Lilly's Taltz (ixekizumab) Receives U.S. FDA Approval for the Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis
-- Taltz is the first and only IL-17A antagonist approved to treat this population --
INDIANAPOLIS,?March 30, 2020?/PRNewswire/ --?Eli Lilly and Company(NYSE: LLY) announced today the?U.S. Food and Drug Administration(FDA) has approved a supplemental Biologics License Application (sBLA) for Taltz??(ixekizumab) injection, 80 mg/mL for the treatment of pediatric patients (ages 6 to under 18) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Psoriasis affects nearly 8 million people in the?U.S.1?Many people living with psoriasis develop symptoms during childhood.2
"As I have often seen in my clinic, psoriasis is particularly challenging for children and adolescents, resulting in itchy and painful symptoms that can feel especially embarrassing for pediatric patients during a crucial developmental period in their young lives," said?Jennifer Cather, M.D.,?Modern Research Associates,?Dallas, Texas. "In the Phase 3 pediatric study, half of patients treated with Taltz achieved completely clear skin after only 12 weeks of treatment. These results and the subsequent FDA approval make a strong case for Taltz as an effective treatment option for doctors to consider for pediatric patients with moderate to severe plaque psoriasis."
Taltz should not be used in patients with a previous serious hypersensitivity, such as anaphylaxis, to ixekizumab or to any of the excipients. Taltz may increase the risk of infection. Other warnings and precautions for Taltz include pre-treatment evaluation for tuberculosis, hypersensitivity, inflammatory bowel disease, and immunizations. See Important Safety Information below.
"At?Lilly, we are working to unite our compassion for individuals with our enthusiasm for scientific discovery in an effort to provide medicines that help make life better for people," said?Patrik Jonsson, senior vice president and president of?Lilly?Bio-Medicines. "We have over five years of data demonstrating that Taltz is a safe and effective treatment option for psoriasis in adults, and with this approval, we're pleased to now be able to offer Taltz to more people living with this challenging condition."
The safety, tolerability and efficacy of Taltz in patients ages 6 to under 18 was demonstrated in a randomized, double-blind, placebo-controlled Phase 3 study that included 171 patients with moderate to severe plaque psoriasis. The co-primary endpoints of the study were the proportion of patients achieving a 75 percent improvement from baseline on their Psoriasis Area and Severity Index score (PASI 75) and a static Physician's Global Assessment of clear or almost clear skin (sPGA 0,1) at Week 12.
Patients were randomized to receive Taltz (20 mg for <25 kg, 40 mg for 25-50 kg or 80 mg for >50 kg through Week 12, with 40 mg, 80 mg or 160 mg starting doses, respectively) or placebo. At 12 weeks, the proportion of patients achieving the co-primary endpoints was superior to placebo with statistically significant difference (P<0.001):
- 89 percent of patients treated with Taltz achieved PASI 75 compared to 25 percent of patients treated with placebo.
- 81 percent of patients treated with Taltz achieved sPGA 0,1 compared to 11 percent of patients treated with placebo.
?View original content to download multimedia:http://www.prnewswire.com/news-releases/lillys-taltz-ixekizumab-receives-us-fda-approval-for-the-treatment-of-pediatric-patients-with-moderate-to-severe-plaque-psoriasis-301031305.html
SOURCE?Eli Lilly and Company