Lilly gets USFDA nod for Taltz(ixekizumab) for Pediatric Patients with Moderate to Severe Plaque Psoriasis

Indianapolis: Eli Lilly and Company have announced that 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. Many people living with psoriasis develop symptoms during childhood.

"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 Phase 3 pediatric study, half of the 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.

Taltz also met all major secondary endpoints in the study (P<0.001), which included the proportion of patients achieving PASI 90, sPGA (0) and PASI 100 at Week 12, and at least a four-point improvement in Itch Numeric Rating Scale (Itch NRS ≥4) among patients with baseline Itch NRS ≥4 at Week 12, as well as PASI 75 and sPGA 0,1 at Week 4.

Overall, the safety profile observed in pediatric patients with plaque psoriasis treated with Taltz every four weeks is consistent with the safety profile in adult patients with plaque psoriasis, with the exception of the frequencies of conjunctivitis (3%), influenza (2%) and urticaria (2%). In this clinical trial, Crohn's disease occurred at a greater frequency in the Taltz group (0.9%) than the placebo group (0%) during the 12-week, placebo-controlled period. Crohn's disease occurred in a total of four Taltz-treated subjects (2.0%) in the clinical trial. The Taltz safety profile has been studied across 13 clinical trials in adult subjects with plaque psoriasis, with over 5,000 patients receiving Taltz, with a total exposure of over 17,000 patient-years.

"Due to limited pediatric psoriasis treatment options available, treating children and adolescents with moderate to severe plaque psoriasis can be challenging," said Stacie Bell, chief scientific and medical officer, National Psoriasis Foundation. "Having more FDA approved pediatric psoriasis treatment options available is a positive step forward in helping relieve the burden of psoriasis for pediatric patients, their families and the health care providers that treat these young patients."

Taltz was first approved by the FDA in March 2016 for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. The FDA also approved Taltz for the treatment of adults with active psoriatic arthritis in December 2017 and for the treatment of adults with active ankylosing spondylitis in August 2019.

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