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GSK’s Bepirovirsen Receives the US FDA’s Fast Track Designation for the Treatment of Hepatitis B

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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

Related News:- GSK Reports the P-III Results for Blenrep (belantamab mafodotin) in Combiantion with BorDex (dexamethasone) to Treat Multiple Myeloma

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Shivani Chandra

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.

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