EAST HANOVER, N.J. - Novartis, a leader in rheumatology and immuno-dermatology, announced the US Food and Drug Administration (FDA) has approved Cosentyx (secukinumab) for the treatment of active enthesitis-related arthritis (ERA) in patients four years and older, and active psoriatic arthritis (PsA) in patients two years and older1. Cosentyx is now the first biologic indicated for ERA and the only biologic treatment approved for both ERA and PsA in pediatric patients in the US. These are the second and third approvals for Cosentyx in a pediatric population in the US, and Cosentyx now has a total of five indications across rheumatology and dermatology1.

'Prior research suggests that despite receiving treatment, some children and adolescents with PsA or ERA can continue to experience symptoms,' said Hermine Brunner, MD, Cincinnati Children's Hospital. 'The findings from the Phase III 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.'

ERA and juvenile PsA (JPsA), subtypes of juvenile idiopathic arthritis (JIA), are autoimmune diseases3,4,5. ERA is characterized by joint swelling and pain where tendons and ligaments attach to bone and may present with low back pain or tenderness at the palpation of the hips6. JPsA is characterized by joint swelling and skin psoriasis and may present with nail changes, inflammation of fingers and/or toes, or psoriatic skin changes in a first-degree relative6. If left untreated, they can lead to high levels of pain and disability3,4,5.

'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,' said Victor Bulto, Head, US Pharmaceuticals, Novartis Pharmaceuticals Corporation. '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 approved pediatric dosing for Cosentyx in children and adolescents is 75 mg (body weight: 15 kg to less than 50 kg) or 150 mg (50 kg or more). It is administered as a subcutaneous injection by a pre-filled syringe or Sensoready pen every four weeks after initial loading doses1. With appropriate guidance/instruction from a healthcare professional, Cosentyx can be administered by an adult caregiver outside of a healthcare provider's office via a single-dose prefilled syringe or Sensoready pen.

The approval is based on data from the Phase III JUNIPERA study, a two-year, three-part, double-blind, placebo-controlled, randomized-withdrawal trial that enrolled 86 children and adolescents aged 2 to 17 years with a confirmed diagnosis of ERA or JPsA according to a modified International League of Associations for Rheumatology classification criteria7. The primary endpoint of the study was time to flare in the treatment period 2 (Week 12 to Week 104)7. In children and adolescents ages 2 to 17 years old, the study demonstrated that patients with active JPsA (n = 34; mean age: 12.2) treated with Cosentyx had a significantly longer time to flare, showing a 85% reduction in the risk of flare (P

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