FDA approves Novartis’s Cosentyx for severe plaque psoriasis

pharmafile | June 2, 2021 | News story | Research and Development  

The FDA has approved Novartis’s Cosentyx for the treatment of children and adolescents with moderate to severe plaque psoriasis.

The approval is based on pivotal Phase III trial data showing that Cosentyx demonstrated superior improvements of skin symptoms compared to placebo.

The Cosentyx clinical profile is supported by five years of adult data showing long-lasting efficacy and a consistent safety profile across moderate to severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis.

Plaque psoriasis is a common, chronic, inflammatory disease that may impact up to 350,000 children worldwide, with onset most common during adolescence.

Clinical Trial Investigator, John Browning, said: “Treating moderate to severe plaque psoriasis in children can be complicated, as we need to balance the ability of a treatment to provide symptom relief while considering the safety profile as the top priority.

“In the paediatric pivotal study, the majority of patients treated with Cosentyx were able to achieve clear or almost clear skin with a safety profile consistent with previous clinical trials in adults.

“Due to the systemic nature of the disease, Cosentyx is a welcome addition as a treatment option for families dealing with this challenging condition.”

Novartis Global Head Development Unit Immunology, Hepatology & Dermatology, Angelika Jahreis said: “The impact of psoriasis on children is much deeper than skin and can potentially lead to life course impairment. Today’s FDA approval further demonstrates our commitment to reimagine medicine for paediatric plaque psoriasis patients.

“With more than 400,000 patients treated in over 100 countries worldwide, we continue to build on the established safety and efficacy profile of Cosentyx, with plans to expand to ten indications over the next ten years.”

Randy Beranek, President and CEO, National Psoriasis Foundation said: “Living with psoriasis is challenging, and can be highly stressful for children and adolescents.

“Having expanded treatment options for this patient population is a step in the right direction to help reduce the burden of plaque psoriasis.”

Novartis has also today shown positive Phase III results with its treatment Cosentyx for patients with juvenile idiopathic arthritis.

Lilly Subbotin

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