GSK’s Bepirovirsen Receives the US FDA’s Fast Track Designation for the Treatment of Hepatitis B
Shots:
- The FTD was granted based on the results from the P-IIb trials incl. (B-Clear) evaluating the safety, efficacy & durability of Bepirovirsen vs PBO in patients (n=440) with chronic HBV infection randomized as those on stable NA (Cohort 1)/ or not (Cohort 2) & (B-Sure) follow-up study evaluating patients achieving a complete or partial response in the (B-Clear) study
- In both trials, patients depicted a clinically meaningful response with Bepirovirsen + oral NAs & the (B-Clear) trial showed the potential of patients with low baseline Hepatitis B surface antigen levels to benefit from bepirovirsen treatment
- Bepirovirsen, an antisense oligonucleotide (ASO), is currently being evaluated in a confirmatory P-III (B-Well) trial
Ref: GSK | Image: GSK
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Shivani was a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She was covering news related to Product approvals, clinical trial results, and updates. We can be contacted at connect@pharmashots.com.
