Novartis' Cosentyx Scores FDA Approval For Arthritis In Children, Adolescents

The FDA has approved Novartis AG's NVS Cosentyx (secukinumab) for active enthesitis-related arthritis (ERA) in four years and older, and active juvenile psoriatic arthritis (JPsA) in patients two years and older. 

• Cosentyx is now the first biologic indicated for ERA and the only biologic treatment approved for ERA and PsA in pediatric patients in the U.S. 
• The approval marks the second and third US pediatric approval this year for Cosentyx.
• Cosentyx now has a total of five indications across rheumatology and dermatology.
• Related content: Benzinga's Full FDA Calendar.
• The approved pediatric dosing for Cosentyx in children and adolescents is 75 mg (15 kg or more to less than 50 kg) or 150 mg (50 kg or more). 
• It is administered subcutaneously by a prefilled syringe or Sensoready pen every four weeks after initial loading doses.
• The Phase 3 JUNIPERA study demonstrated that JPsA patients and ERA patients treated with Cosentyx showed an 85% and 53% reduction in the risk of flare versus placebo, respectively.
• Novartis has filed a regulatory submission for Cosentyx in ERA and JPsA in Europe with a decision anticipated in the coming months.
• Price Action: NVS shares are up 0.50% at $86.74 during the premarket session on the last check Thursday.