Taltz is a monoclonal antibody designed to selectively bind with interleukin 17A (IL-17A) and inhibit its interaction with the IL-17 receptor
Eli Lilly and Company's Corporate Center in Indianapolis, Indiana. (Credit: Momoneymoproblemz.)
Eli Lilly and Company (Lilly) has obtained the US Food and Drug Administration (FDA) approval for its Taltz (ixekizumab) to treat a type of plaque psoriasis in paediatric patients.
The US regulatory agency has approved the company’s supplemental biologics license application (sBLA) for Taltz, to treat patients aged between ages six to 18 years, with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Psoriasis is a skin disorder that causes skin cells to multiply. The disease affects around eight million people in the US, and many people living with psoriasis would develop the symptoms during childhood.
National Psoriasis Foundation chief scientific and medical officer Stacie Bell said: “Due to limited pediatric psoriasis treatment options available, treating children and adolescents with moderate to severe plaque psoriasis can be challenging.
“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.”
The FDA approval is based on a Phase 3clinical study Taltz in paediatric patients
Taltz is a monoclonal antibody designed to selectively bind with interleukin 17A (IL-17A), a naturally occurring cytokine that is involved in normal inflammatory and immune responses, and inhibit its interaction with the IL-17 receptor.
The US FDA has approved Taltz based on a Phase 3, multicentre, randomised, double-blind, placebo-controlled study to evaluate safety, tolerability and efficacy of Taltz in paediatric patients.
The study has reached its co-primary endpoints including the proportion of patients achieving a 75% improvement from baseline on their Psoriasis Area and Severity Index score and a static Physician’s Global Assessment of clear or almost clear skin at Week 12.
In addition, Taltz has also met all major secondary endpoints in the study, which includes the proportion of patients achieving PASI 90, sPGA and PASI 100 at Week 12, and at a minimum of four-point improvement in Itch Numeric Rating Scale at Week 12.
Lilly Bio-Medicines president and senior vice president Patrik Jonsson said: “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.
“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.”