Johnson & Johnson Submits sBLA to the US FDA for Subcutaneous Induction Regimen of Tremfya (Guselkumab) for Ulcerative Colitis
Shots:
- J&J has submitted sBLA of Tremfya SC induction regimen to the US FDA for treating mod. to sev. active ulcerative colitis, based on P-III (ASTRO) trial
- The P-III trial assessed Tremfya in UC adults, failed or were intolerant to prior therapies, randomized to (400mg, SC, wks. 0, 4 & 8 followed by 200mg, SC, Q4W) or (400mg, SC, wks. 0, 4 & 8, followed by 100mg, SC, Q8W) or PBO. Maintenance doses (200mg, SC, Q4W & 100mg, SC, Q8W) are similar to P-III (QUASAR) study
- Trial met its 1EP with Tremfya (400mg), showing significant clinical remission at wk.12, along with 2EPs of endoscopic & histologic-endoscopic mucosal improvement (HEMI); safety findings aligned with the QUASAR trial. Data will be highlighted at future conferences
Ref: Johnson | Image: Johnson
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
