Johnson & Johnson has applied to the US Food and Drug Administration (FDA) seeking approval for Simponi (golimumab) to treat paediatric ulcerative colitis (UC).
The supplemental Biologics License Application (sBLA) aims for expanded approval for Simponi to treat children aged two and older with moderately to severely active UC.
Golimumab is already approved for treating adults with moderately to severely active UC.
Simponi is an anti-TNF biologic that blocks the TNF-alpha (tumour necrosis factor-alpha) protein.
The prescription medicine is approved in the US to treat adults with moderate to severe rheumatoid arthritis (RA) in combination with methotrexate (MTX), adults with active psoriatic arthritis (PsA) either alone or with MTX and adults with active ankylosing spondylitis (AS).
Golimumab is also approved in Europe, Canada, Japan, and other countries for treating these conditions in adults.
The latest sBLA is supported by data from the PURSUIT programme. This includes multi-centre, open-label studies that evaluate the efficacy, safety, and pharmacokinetics of subcutaneous Simponi for treating paediatrics UC.
The programme included Phase 3 PURSUIT 2 study and Phase 1 PURSUIT PEDIATRIC PK study.
Johnson & Johnson Innovative Medicine gastroenterology disease area lead and vice president Esi Lamousé-Smith said: “This submission marks an important step in addressing the unique and pressing high unmet needs of children and adolescents living with ulcerative colitis, a challenging and lifelong inflammatory disease.
“At Johnson & Johnson, we are committed to designing clinical programs that prioritize underrepresented populations, including paediatrics patients living with immune-mediated diseases, to ensure access to safe and effective treatment options. We look forward to working with the Agency in their review of this Simponi paediatrics application.”
In a separate development, Johnson & Johnson announced that the FDA has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for SC Rybrevant (amivantamab-vmjw).
It is a fixed combination of amivantamab and recombinant human hyaluronidase, for patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations.
The CRL is related to observations made during a standard pre-approval inspection at a manufacturing facility.
The intravenous (IV) formulation of Rybrevant is already approved and is not impacted by the CRL.
