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2 clusters · 18 sources · 3 days · First seen · Last updated

FDA approval of GSK Hibsago for hepatitis B

Overview

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

The treatment is designed for use alongside existing antiviral therapies for adults without cirrhosis who have undergone nucleos(t)ide analogue therapy for at least six months and possess suppressed HBV DNA levels and low hepatitis B surface antigen (HBsAg) levels. Clinical trials indicated that 19% of patients achieved a functional cure, defined as undetectable HBV DNA and HBsAg for at least 24 weeks after ceasing all treatment. In subgroups with HBsAg levels of 1,000 IU/mL or less, the functional cure rate reached 26%.

Hibsago was granted breakthrough therapy status and received accelerated approval. The medication carries a boxed warning regarding serious liver reactions and thrombocytopenia, which may cause life-threatening bleeding. Other risks include vasculitis and worsening kidney function, necessitating regular blood monitoring.

Entities

Hibsago · FDA · GSK · Ionis Pharmaceuticals · bepirovirsen

Timeline

  1. [HEALTH] 4 sources
    FDA approves GSK drug Hibsago for chronic hepatitis B

    The FDA has approved GSK’s Hibsago, the first antisense oligonucleotide for chronic hepatitis B, potentially allowing some patients to stop long-term antiviral therapy.

  2. [HEALTH] 14 sources
    GSK's Hibsago approved by FDA for chronic hepatitis B

    The FDA has approved GSK’s Hibsago (bepirovirsen), the first antisense oligonucleotide for chronic hepatitis B, offering a potential functional cure for certain patients.

Sources

bhaskarhindi.com · contagionlive.com · cubaheadlines.com · diariodesalud.com.do · fehmarn24.de · finchannel.com · it-boltwise.de · kurierverlag.de · medicaldaily.com · newsinspace.kr · notiulti.com · pharmabiz.net · pharmexec.com · saludiario.com · samacharnama.com · techgear.gr · theedadvocate.org · tmtpost.com