FDA approves Cosentyx for children with juvenile PsA, enthesitis-related arthritis
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The FDA has approved secukinumab for the treatment of active psoriatic arthritis in patients aged 2 years and older, and for active enthesitis-related arthritis in those aged 4 years and older.
The announcement, issued Dec. 22, makes secukinumab (Cosentyx, Novartis) the first biologic indicated for enthesitis-related arthritis, and the only biologic agent approved for both enthesitis-related arthritis and juvenile PsA in the United States, according to Novartis.
“The FDA approvals for jPsA and ERA follow the approval of Cosentyx as a first-line systemic treatment for pediatric psoriasis earlier this year, and further reinforce the commitment of Novartis to the pediatric community,” Victor Bulto, head of U.S. pharmaceuticals at Novartis, said in a company press release. “Cosentyx is a proven medicine with a history of efficacy and safety across several systemic inflammatory conditions, with more than 500,000 patients treated worldwide since launch.”
The FDA based its approval on data from the phase 3 JUNIPERA, a 2-year, three-part, double-blind, placebo-controlled, randomized-withdrawal trial of 86 children and adolescents aged 2 to 17 years. Participants arrived with a confirmed diagnosis of ERA or PsA. The primary endpoint was time to flare during the study’s second period, stretching from weeks 12 to 104.
According to the study, juvenile patients with active PsA who received secukinumab demonstrated significantly longer time to flare, with an 85% reduction in the risk for flare (P < .001), compared with placebo. In addition, patients with active ERA who were treated with the drug enjoyed a longer time to flare, with a 53% reduction in the risk for flare versus placebo.
Meanwhile, safety findings were consistent with the known the drug’s known profile in the treatment of plaque psoriasis, PsA, non-radiographic axial spondyloarthritis and ankylosing spondylitis.
Data from the JUNIPERA trial were previously presented at the EULAR 2021 Congress, in June, and the American College of Rheumatology Convergence 2021 meeting, in November.
“Prior research suggests that despite receiving treatment, some children and adolescents with PsA or ERA can continue to experience symptoms,” Hermine Brunner, MD, of Cincinnati Children's Hospital, and lead researcher of the JUNIPERA trial, said in the Novartis press release. “The findings from the phase 3 JUNIPERA trial show that pediatric patients treated with secukinumab demonstrated marked responses throughout the treatment period. This approval is positive news for some patients who continue to struggle with painful symptoms like inflammation of the joints and swollen fingers and toes.”
The approved dose for the drug in children and adolescents is 75 mg among those weighing 15 kg to less than 50 kg, or 150 mg in those weighing 50 kg or more. It is administered via subcutaneous injection every 4 weeks after the initial loading doses. According to Novartis, secukinumab can be administered by an adult caregiver outside of a health care provider’s office using a single dose prefilled syringe or Sensoready pen.
These are the second and third approvals for secukinumab in pediatric patients in the United States. The drug now has a total of five indications across rheumatology and dermatology.
Secukinumab received approval in the European Union in July 2020 as a first-line systemic treatment for pediatric psoriasis in patients aged 6 to less than 18 years, and recently received approval in the United States and China. In 2021, the drug was approved in Japan to treat PsA and psoriasis in patients aged 6 years and older, as well as generalized pustular psoriasis.
Novartis also announced it has filed regulatory submissions for secukinumab to treat ERA and juvenile PsA in Europe, with a decision anticipated in the coming months, according to the release.
“The symptoms of PsA and ERA can be debilitating for children and adolescents living with these chronic conditions, impacting their daily lives,” Tiffany Westrich-Robertson, CEO of the International Foundation for Autoimmune & Autoinflammatory Arthritis, said in the release. “It is encouraging to see an additional treatment option for these underserved patient populations.”
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