Johnson & Johnson Seeks FDA Approval for TREMFYA® to Treat Paediatric Psoriasis and Arthritis
Tuesday, December 03, 2024
Johnson & Johnson has submitted two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) seeking approval to expand the use of TREMFYA® (guselkumab) for children.
TREMFYA® is a fully-human monoclonal antibody that targets the IL-23 pathway, which plays a key role in immune-mediated diseases such as psoriasis and psoriatic arthritis.
Plaque psoriasis is a chronic immune-mediated condition that affects the skin, causing itchy or painful scaly patches. Approximately one-third of cases begin during childhood, and the condition can have significant physical and psychological impacts on young patients.
Juvenile psoriatic arthritis, a rare form of juvenile idiopathic arthritis, combines joint inflammation and psoriasis and may first present with skin symptoms before arthritis develops.
The medication is already approved in the U.S. and several other countries for treating adults with moderate-to-severe plaque psoriasis, active psoriatic arthritis, and ulcerative colitis.
The applications aim to gain approval for treating moderate-to-severe plaque psoriasis (PsO) in children aged six years and older, and active juvenile psoriatic arthritis (jPsA) in those aged five years and older.
The application for plaque psoriasis is supported by data from the Phase 3 PROTOSTAR trial conducted in paediatric patients, alongside pharmacokinetic data from prior studies involving adults.
For juvenile psoriatic arthritis, the submission relies on data extrapolated from adult PsA studies and additional findings from the PROTOSTAR study.
Johnson & Johnson highlighted that these applications reflect their focus on addressing gaps in treatment options for children and adolescents living with immune-mediated conditions.
By investigating TREMFYA® in younger age groups, the company aims to expand its use in managing these complex and often debilitating diseases.
Source: jnj.com
