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[HEALTH] · United States · 14 sources

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Part of situation: FDA approval of GSK Hibsago for hepatitis B (2 clusters)

GSK's Hibsago approved by FDA for chronic hepatitis B

Hibsago bepirovirsen chronic hepatitis B GSK antisense oligonucleotide

The U.S. Food and Drug Administration (FDA) has approved Hibsago (bepirovirsen), an injectable antisense oligonucleotide (ASO) developed by GSK, for the treatment of chronic hepatitis B in certain adults. This marks the first FDA approval of an ASO for this condition.

The treatment is intended for use in combination with existing antiviral therapies for adults without cirrhosis who have been on nucleos(t)ide analogue therapy for at least six months, have suppressed HBV DNA levels, and possess hepatitis B surface antigen (HBsAg) levels of 3,000 IU/mL or less. Clinical trials (B-Well 1 and 2) demonstrated that 19% of patients achieved a functional cure—defined as undetectable HBV DNA and HBsAg for at least 24 weeks after stopping all treatment—compared to 0% in the placebo group. In a subgroup with HBsAg levels of 1,000 IU/mL or less, the functional cure rate rose to 26%.

Hibsago carries a boxed warning regarding serious liver reactions and thrombocytopenia (low platelet counts), which may lead to life-threatening bleeding. Other potential risks include worsening kidney function and vasculitis. Regular blood monitoring is required during treatment. The FDA also authorized the Roche Elecsys HBsAg II quant II RxDx assay to assist in patient selection and monitoring.

Entities

FDA · GSK · Hibsago · Ionis Pharmaceuticals · Roche · U.S. Food and Drug Administration · bepirovirsen

Claims

What the coverage asserts, and how many sources carry each claim.

Sources

약 끊고도 B형간염 억제 가능성…미 FDA, 베피로비르센 승인 [www.newsinspace.kr]
FDA autoriza el primer tratamiento contra la hepatitis B crónica [www.saludiario.com]
La FDA aprueba el primer tratamiento de su tipo para la hepatitis B crónica [www.diariodesalud.com.do]
FDA aprueba Hibsago de GSK para tratar la hepatitis B crónica - Notiulti [www.notiulti.com]
FDA: OK para Hibsago de GSK [www.pharmabiz.net]
अमेरिका ने हेपेटाइटिस बी के नए इलाज को दी मंजूरी, मरीज एंटीवायरल दवा लेना कर सकेंगे बंद [samacharnama.com]
New Hepatitis B Breakthrough: A Cure for Millions Without Cirrhosis? - The Edvocate [www.theedadvocate.org]
अमेरिका ने हेपेटाइटिस बी के नए इलाज को दी मंजूरी, मरीज एंटीवायरल दवा लेना कर सकेंगे बंद | US approves new hepatitis B treatment [www.bhaskarhindi.com]
FDA Approves Bepirovirsen, First Antisense Therapy for Chronic Hepatitis B | Contagion Live [www.contagionlive.com]
FDA Approves First-of-Its-Kind Chronic Hepatitis B Treatment [finchannel.com]
Hibsago Hepatitis B Shot Kept Virus Controlled in Nearly 1 in 5 Off Treatment but Carries Boxed Warning [www.medicaldaily.com]
FDA Approves Hibsago (Bepirovirsen) for Chronic Hepatitis B [www.pharmexec.com]
Hibsago: Εγκρίθηκε η πρώτη λειτουργική θεραπεία για τη χρόνια Ηπατίτιδα Β [www.techgear.gr]
乙肝，第一次把“治愈”写进终点-钛媒体官方网站 [www.tmtpost.com]