Novartis’ Cosentyx Receives the US FDA’s Approval to Treat Enthesitis-Related Arthritis and Psoriatic Arthritis
Shots:
- The approval is based on the P-III JUNIPERA study, enrolling 86 children and adolescents which showed that patients with active JPsA (n = 34; mean age: 12.2) treated with Cosentyx had a longer time to flare, showing an 85% reduction in the risk of flare vs. PBO
- 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), administered as an SC injection by a pre-filled syringe or Sensoready pen Q4W after initial loading doses
- Cosentyx received EU approval as a 1L systemic treatment in Jul 2020 for pediatric psoriasis in patients aged 6 to 18 yrs old and also received approval in the US and China
Ref: Novartis | Image: Novartis
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