Benzinga | Jun 2, 2021 07:02AM EDT

Novartis's Cosentyx Wins FDA Approval For Psoriasis In Pediatric Patients

* The FDA has approved Novartis AG's (NYSE:NVS) Cosentyx (secukinumab) to treat moderate to severe plaque psoriasis in pediatric patients six years and older and are candidates for systemic therapy or phototherapy.

* The approved dosing is 75 mg or 150 mg depending on the child's weight at the time of dosing and is administered by subcutaneous injection every four weeks after an initial loading regimen.

* After initial counseling and proper training in injection technique, Cosentyx can be administered outside of a healthcare provider's office via a single-dose prefilled syringe or Sensoready pen.

* The approval is based on two Phase 3 studies. The data showed Cosentyx reduced psoriasis severity at Week 12 compared with placebo, as demonstrated by the following efficacy results by baseline.

* Related content: Benzinga's Full FDA Calendar

* Price Action: NVS shares are up 1.02% at $89.02 during the premarket session on the last check Wednesday.