Novartis' Cosentyx Receives FDA Approval for Pediatric Moderate-to-Severe Plaque Psoriasis in Patients Aged 6–18

June 02, 2021 /BioonBIOON/ --Novartis(Novartis) recently announced that the U.S. Food and Drug Administration (FDA) has approved the anti-inflammatory drug Cosentyx (Chinese trade name: Keshanting, generic name: secukinumab, commonly known as "Sujin monoclonal antibody") for the treatment of pediatric patients aged 6 years and older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

It is worth noting that,This is the first U.S. approval of Cosentyx for use in the pediatric population.The clinical profile of Cosentyx is supported by 5-year adult data, demonstrating long-term efficacy and a consistent safety profile in the treatment of moderate-to-severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis. Regarding dosing, the pediatric dose of Cosentyx is 75 mg or 150 mg, depending on the child’s body weight at the time of administration (75 mg recommended for children weighing <50 kg, and 150 mg for those weighing ≥50 kg), and is administered subcutaneously every 4 weeks following an initial loading regimen.

Plaque psoriasis is a chronic inflammatory disease affecting up to 350,000 children worldwide, with onset most commonly occurring during adolescence. The impact of this condition on children extends far beyond the skin, leading to a deterioration in quality of life and potentially exerting long-lasting effects on this vulnerable patient population. Compared with their peers, children with psoriasis experience a poorer quality of life due to symptoms such as pruritus and fatigue, alongside feelings of stigma. These factors, in turn, can adversely affect their emotional well-being and academic performance.

With this approval, Cosentyx will provide a first-line systemic therapy for pediatric patients with psoriasis in the United States.Currently, Cosentyx has been approved for four indications,NovartisPlans to expand to 10 indications over the next decade.

`Plaque psoriasis`

John Browning, clinical investigator for the Cosentyx pediatric trial and Associate Professor of Pediatrics and Dermatology at the University of Texas, stated: “Treating moderate-to-severe plaque psoriasis in children can be complex, as we must balance the drug's efficacy in relieving symptoms while prioritizing safety. In the pivotal pediatric study, the majority of patients treated with Cosentyx achieved complete or near-complete clearance of skin lesions, with a safety profile consistent with previous adultClinical TrialsConsistent. Given the systemic nature of the disease, Cosentyx is a welcome addition to the family of treatment options for managing this challenging disease.”

NovartisImmunology、Global Head of Development for Hepatology and Dermatology Dr. Angelika Jahreis, MD, said: “Psoriasis affects children far beyond the skin, potentially compromising their life course. TodayFDAThe approval further underscores our commitment to redesigning medicines for pediatric patients with plaque psoriasis. To date, Cosentyx has treated over 400,000 patients in more than 100 countries worldwide, and building on the established safety and efficacy profile of Cosentyx, we continue to plan for its expansion to 10 indications over the next 10 years.”

This approval is based on two Phase 3 studies evaluating Cosentyx for the treatment of pediatric patients aged 6 to under 18 years with plaque psoriasis. The safety profile reported in these trials was consistent with that observed in adult plaque psoriasis trials, with no new safety signals identified.

The first study evaluated efficacy and safety. It was a randomized, double-blind, placebo- and active-controlled study with a 52-week treatment period (total duration of 236 weeks), enrolling 162 pediatric patients aged 6 years and older with severe plaque psoriasis.Data show that, compared with placebo, Cosentyx reduces the severity of psoriasis at Week 12.Efficacy results for the two co-primary endpoints stratified by baseline weight for the approved dose (<50 kg, 75 mg dose; >50 kg, 150 mg dose): (1) proportion of patients achieving at least 75% improvement in the Psoriasis Area and Severity Index score (PASI75 response: 55% for the 75 mg dose vs 10% for placebo [N=22 and N=20]; 86% for the 150 mg dose vs 19% for placebo [N=21 and N=21]; overall Cosentyx 70% vs 15% overall placebo [N=43 and N=41]); (2) proportion of patients achieving a skin response of an Investigator’s Global Assessment (IGA) score of 0 or 1 (IGA 0/1: clear or almost clear skin) (32% for the 75 mg dose vs 5% for placebo; 81% for the 150 mg dose vs 5% for placebo; overall Cosentyx 56% vs 5% overall placebo).

The second study evaluated safety in a randomized, open-label, Phase 3, 208-week trial enrolling 84 pediatric patients aged 6 years and older with moderate-to-severe plaque psoriasis.

Psoriasis is a lifelong, systemic inflammatory disease that severely impacts patients' physical and emotional quality of life. One-third of psoriasis cases begin in childhood, with onset most commonly occurring during adolescence. Moderate-to-severe psoriasis affects over 350,000 children worldwide and can have "more-than-skin-deep" impacts, as the physical and psychological burden of the disease disrupts critical developmental periods. Between 1970 and 2000, the incidence of pediatric psoriasis in the United States more than doubled, and rising incidence rates have been observed in multiple countries. With only a few approved treatment options available, the unmet medical need remains high.

Cosentyx is the first fully human monoclonal antibody drug that specifically targets and inhibits interleukin-17A (IL-17A). It selectively targets and blocks the activity of circulating IL-17A, thereby reducing immune system activity and improving disease symptoms. Research reveals that IL-17A drives the body in multiple# Autoimmunityplayed an important role in the immune response of inflammatory diseases, including psoriatic arthritis (PsA), plaque psoriasis (PsO), ankylosing spondylitis (AS), and non-radiographic axial spondyloarthritis (nr-axSpA).

Cosentyx was approved for marketing in January 2015 and is currently approved for four indications (PsO, PsA, AS, nr-axSpA). Cosentyx is supported by robust clinical evidence, including 5-year data for the top three indications (PsO, PsA, AS) as well as real-world evidence data. These data reinforce Cosentyx’s unique position as a rapid, sustained, and comprehensive treatment across axSpA, PsA, and psoriasis. Since its launch, over 400,000 patients worldwide have been treated with Cosentyx.

In China, Cosentyx® was approved by the National Medical Products Administration (NMPA) in late April 2020 for adult patients with ankylosing spondylitis (AS) who have demonstrated an inadequate response to conventional therapy. This is the second indication for Cosentyx® approved in China, following its March 2019 approval for the treatment of moderate-to-severe plaque psoriasis (PsO), and it is also currently the first and only interleukin inhibitor approved in China for the treatment of ankylosing spondylitis (AS).

In mid-June 2020, the Cosentyx® Sensoready® Pen was approved in China. As an upgraded version of the Cosentyx® pre-filled syringe, the Cosentyx® Sensoready® Pen comprehensively optimizes the original administration method. Its "one-touch" operation reduces injection difficulty and enhances the patient treatment experience, while effectively preventing drug waste caused by operational errors, bringing a more convenient, safe, and efficient treatment experience to a vast number of Chinese patients with moderate-to-severe plaque psoriasis and ankylosing spondylitis. (Bioon.com)

Source: Novartis Cosentyx receivesFDA approval for treatment of children and adolescents with moderate to severe plaque psoriasis