J&J Request FDA Approval for Crohn’s disease Treatment

Johnson & Johnson is requesting FDA clearance for Tremfya, a treatment for Crohn’s disease, through a supplementary biologics licence application.

This is the business’s second application for the inflammatory bowel disease treatment.

Tremfya is a monoclonal antibody that is exclusively human and goes after IL-23, a cytokine that has been linked to immune-related illnesses including Crohn’s disease.

If authorised, it may provide patients and providers more options when it comes to medical treatment.

Johnson & Johnson innovative medicine immunology global therapeutic area head David Lee explained: “TREMFYA has the potential to be a differentiated treatment option for patients who seek symptom relief and sustained remission.

“We look forward to working with the agency in their review of the data supporting the application as we continue to innovate for people living with inflammatory bowel disease.”