Benzinga | Dec 23, 2021 08:21AM EST

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

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.