The FDA has approved Novartis AG's (NYSE: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.
