Johnson & Johnson Reports sBLA Submission of Tremfya (Guselkumab) to the US FDA for Treating Ulcerative Colitis
Shots:
- The sBLA was supported by the P-III (QUASAR) trial assessing its safety & efficacy to treat moderately to severely active UC patients with inadequate response or intolerant to traditional treatment, previous biologics & JAK inhibitors. Trial further included a P-IIb dose-ranging induction study, a confirmatory P-III induction study & a P-III maintenance study
- The results demonstrated improved symptoms, patient-reported outcomes incl. fatigue & disease activity measures like endoscopic & histologic remission
- The 12 wks. results from the P-III (QUASAR) induction trial were highlighted at the DDW’23. The 44 wks. P-III (QUASAR) maintenance trial data will be highlighted at further medical meetings
Ref: Johnson & Johnson | Image: Johnson & 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.
