EMA CHMP positive opinion paves way for Cosentyx to become a first-line systemic treatment in pediatric psoriasis
CHMP opinion based on two Phase III studies showing Cosentyx provides fast and strong skin clearance and significant improvement in quality of life1
Moderate-to-severe psoriasis affects more than 350,000 children worldwide2, with the physical and psychological burden disrupting important formative years3
Potential new indication reinforces Cosentyx leadership in immuno-dermatology and rheumatology and follows recent EU approval in non-radiographic axial spondyloarthritis (nr-axSpA), with plans to expand to 10 indications over the next 10 years
Basel, June 26, 2020 - Novartis, a leader in immuno-dermatology and rheumatology, today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Cosentyx (secukinumab) for the treatment of moderate-to-severe plaque psoriasis in children and adolescents aged 6 to <18 years.
"Psoriasis affects children much deeper than just the skin and can lead to deterioration of quality of life, potentially having a lasting impact on this vulnerable patient population," said Todd Fox, Global Head of Medical Affairs Immunology, Hepatology and Dermatology at Novartis. "This is our second positive CHMP opinion for Cosentyx this year alone, following on from recent EC approval in nr-axSpA. The latest positive opinion is an important step forward in our commitment to reimagining care for children with psoriasis, giving them freedom to enjoy full and active lives."
The positive CHMP opinion is based on two Phase III international studies in children and adolescents aged 6 to <18 years, one open-label, two-arm, parallel-group, multicentre study with moderate-to-severe plaque psoriasis and one randomized, double-blind, placebo and etanercept-controlled study with severe plaque psoriasis. The studies showed both low-dose (75-150 mg) and high-dose (75-300 mg) of Cosentyx were highly efficacious in rapidly improving skin symptoms and quality of life, with a favorable safety profile up to 52 weeks.
In children with moderate-to-severe plaque psoriasis, the low dose of Cosentyx provided fast and strong skin clearance, with 93% achieving Psoriasis Area Severity Index (PASI) 75 as early as Week 12, 69% achieving PASI 90 at Week 12 and 88% at Week 24, 59.5%% achieving completely clear skin (PASI 100) by Week 12 and 67% by Week 24. In patients with severe psoriasis, the low dose of Cosentyx ensured sustained skin clearance through Week 52, with PASI 90 achieved in 75% of patients1. Differences in PASI 75 in patients with severe psoriasis treated with Cosentyx were seen as early as Week 4 and in patients with moderate-to-severe psoriasis as early as Week 2.
Half of children with moderate-to-severe plaque psoriasis treated with low dose of Cosentyx reported complete relief from symptom burden of psoriasis on their quality of life by as early as Week 12, as measured by Children’s Dermatology Life Quality Index (CDLQI) 0/1 responses. In children with severe plaque psoriasis treated with low dose of Cosentyx, 44.7% reported complete relief by Week 12, with 60.6% by Week 52. Cosentyx safety profile of both the low dose and high dose is comparable and consistent with the established adult psoriasis indication. No new safety signals were observed in children.
Phase III data in moderate-to-severe plaque psoriasis were presented as a late breaking abstract at the 2020 American Academy of Dermatology Virtual Meeting Experience (AAD VMX) in June 20204
Psoriasis is a life-long debilitating systemic inflammatory disease that significantly impacts patients’ quality of life, both physically and emotionally5. One-third of psoriasis cases begin in childhood and of these the onset is most common during adolescence6. Moderate-to-severe psoriasis affects more than 350,000 children worldwide and may impact children "deeper than the skin", with the physical and psychological burden of psoriasis disrupting important formative years2. The incidence of pediatric psoriasis has more than doubled between 1970 and 2000 in the US and an upward trend in incidence of psoriasis has been observed in several countries5,6. There are only a few approved treatment options available and the unmet medical need remains high3.
About Cosentyx (secukinumab)
Cosentyx is the first and only fully-human biologic that directly inhibits interleukin-17A (IL-17A), an important cytokine involved in the inflammation and development of psoriatic arthritis (PsA), moderate-to-severe plaque psoriasis (PsO), ankylosing spondylitis (AS) and nr-axSpA7,8,9.
Cosentyx is backed by robust clinical evidence, including five-year data across three indications of PsO, PsA and AS, as well as data from real world evidence10-15. These data strengthen the unique position of Cosentyx as a rapid and long-lasting comprehensive treatment across axSpA, PsA and psoriatic disease, with more than 340,000 patients treated worldwide with Cosentyx since launch16-18.