J&J: applies to FDA for Tremfya in pediatrics

(CercleFinance.com) - Johnson & Johnson announces that it has submitted two supplemental Biologics License Applications (sBLAs) to the FDA for approval of Tremfya (guselkumab) in children aged 6 and over with moderate-to-severe plaque psoriasis, and aged 5 and over with active juvenile psoriatic arthritis.


These submissions are based on Phase 3 studies and pharmacokinetic analyses from several studies.

Tremfya is the first monoclonal antibody to target a cytokine involved in immune diseases.

This initiative aims to fill a critical gap in the treatment of children and adolescents suffering from these disabling pathologies.


Copyright (c) 2024 CercleFinance.com. All rights reserved.