Jun 26, 2020: “Novartis, a leader in immuno-dermatology and rheumatology, announced the Committee for Medicinal Products for Human Use (CHMP) of the 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.”
Novartis PREVENT data show Cosentyx® for relief in axial spondyloarthritis
Novartis Cosentyx® gains fourth indication in EU with first-in-class approval in axial spondyloarthritis spectrum
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 patients.
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 2020.”
