Novartis stakes another PhIII win for Cosentyx, goes deeper into pediatric markets
Just hours after the FDA cleared Novartis’ Cosentyx for its first pediatric indication, the company is following up with more positive data on another: juvenile idiopathic arthritis, or JIA.
The results from the Phase III JUNIPERA study, Novartis says, pave the way for regulatory submissions slated for “the coming weeks,” potentially carving out another big market for the top-selling blockbuster drug that’s facing down rivals from every direction in intensely competitive arenas.
Without providing the numbers — they are being reserved for a presentation at the EULAR 2021 Annual European Congress of Rheumatology — Novartis says Cosentyx beat placebo in delaying the time to flare, meaning that patients on the drug went longer without their symptoms worsening (p < 0.001).
On other measures of response, Cosentyx also proved superior while maintaining a clean score on the safety front after two years of treatment.
The JUNIPERA study also demonstrated sustained efficacy for Cosentyx with more patients achieving and maintaining the JIA American College of Rheumatology (ACR) 30 and JIA ACR 70 responses from Week 12 to Week 104 vs placebo. Cosentyx demonstrated a favorable safety profile with no new safety signals reported in pediatric patients (age 2 to 17 years) with two years of treatment.
The study enrolled 86 children and adolescents between the ages of 2 and 17, all with a confirmed diagnosis of either juvenile psoriatic arthritis or enthesitis-related arthritis, which are two subtypes of JIA.
By Novartis’ estimates, the disease affects a total of 2 million people around the world.
“JPsA and ERA are associated with high levels of pain and functional disability, which can impact children as young as two years of age,” said Todd Fox, who leads up medical affairs for immunology, hepatology and dermatology at Novartis.
Many of these children still find themselves with active disease as adults, added JUNIPERA lead investigator Hermine Brunner.
Although Cosentyx has proven lucrative for Novartis, consistently ranking at the top of its revenue reports for new drugs with $1.053 billion in sales just in Q1 of 2021, it faces significant competition in all of the inflammatory diseases it’s approved to treat. In JIA specifically, the IL-17A inhibitor would be going up against AbbVie’s Humira and Amgen’s Enbrel as well as Roche’s Rituxan and Actemra.