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FDA approves first-of-its-kind hepatitis B drug from GSK and Ionis

FDA approves first-of-its-kind hepatitis B drug from GSK and Ionis

New Capabilities

Hibsago helped about one in five trial patients reach undetectable virus and stop lifelong antiviral treatment

2 days ago: FDA approves Hibsago with boxed warning

Overview

Updated Yesterday

The Food and Drug Administration approved Hibsago on October 20, the first drug shown to clear chronic hepatitis B without lifelong treatment. In two late-stage trials, about one in five patients who took it reached undetectable virus levels and stayed off antiviral drugs for at least six months.

Chronic hepatitis B affects roughly 240 million people worldwide, including 1.7 million in the US. Standard drugs suppress the virus but require daily pills for life, and only 1-4% of patients achieve a durable cure. Hibsago, from GSK and Ionis, is an RNA-based medicine that blocks the virus from replicating and spurs an immune response.

The approval carries a boxed warning for liver inflammation and low platelet counts, and patients need frequent blood tests during the six-month course. GSK has not disclosed the US list price. The company expects peak annual sales above £2 billion and calls the drug central to its £40 billion revenue goal for 2031.

Why it matters

If Hibsago delivers, millions of hepatitis B patients could stop daily antiviral pills for the first time, shifting the disease from lifelong management toward cure.

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Key Indicators

19%
Functional cure rate in trials
Patients with undetectable virus 24 weeks after stopping all treatment, versus none on placebo.
24%
Patients able to stop existing medicine
Share of Hibsago recipients who met requirements to halt antivirals in the two Phase 3 trials.
240M
People with chronic hepatitis B worldwide
GSK's estimate; 1.7 million of them live in the US.
~$3B
Projected peak annual sales
Jefferies estimate; GSK says peak sales should exceed £2 billion.
1-4%
Functional cure rate with current care
Share of patients who clear the virus long-term on existing antivirals.

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People Involved

Organizations Involved

Timeline

2019 October 2026

3 events Latest: 2 days ago
  1. FDA approves Hibsago with boxed warning

    Latest Regulatory Approval

    US approval for chronic hepatitis B in certain adults without cirrhosis; first antisense drug for the disease. Roche companion diagnostic also cleared.

  2. Japan approves Hibsago

    Regulatory

    The drug wins its first regulatory clearance from Japan's regulator.

  3. GSK licenses bepirovirsen from Ionis

    Partnership

    GSK signs a collaborative development and licensing deal; Ionis is eligible for milestone payments and 10-12% royalties.

Scenarios

1

Hibsago becomes a hepatitis B blockbuster

Possible Resolves by End of 2028

Discussed by: Jefferies analyst Michael Leuchten

GSK reports quarterly sales that build toward the $3 billion peak forecast, driven by patients who fail or want to stop standard antivirals. The functional cure results published in the New England Journal of Medicine give prescribers evidence to support switching.

2

Safety monitoring and pricing stall Hibsago uptake

Possible Resolves by End of 2027

Discussed by: Jefferies analyst Michael Leuchten

The boxed warning for liver reactions and low platelets, plus weekly or bi-weekly lab tests, limits use to specialty centers. If the list price lands poorly against cheap lifelong generics, payers restrict coverage and sales lag the £2 billion peak expectation.

3

Hibsago wins European and Chinese approvals

Likely Resolves by End of 2027

Discussed by: GSK company statements; BioWorld

The drug is already approved in Japan and under regulatory review in China and Europe. Clearances in those regions would expand the addressable market well beyond the US, where 1.7 million people live with chronic hepatitis B.

Historical Context

2 moments from history that rhyme with this story — and how they unfolded.

December 2013 - 2014

Sovaldi and the hepatitis C cure (2013-2014)

Gilead's Sovaldi (sofosbuvir) cured more than 90% of hepatitis C patients in 8 to 12 weeks. The roughly $84,000 per-course price triggered a national debate over drug costs.

Then

Demand overwhelmed Gilead's supply, and insurers struggled with the cost of treating millions of patients.

Now

Hepatitis C became the first chronic viral infection to be broadly curable, and the WHO set global elimination targets.

Why this matters now

Both are antivirals marketed as cures for chronic liver infections. Hepatitis B is harder because the virus persists inside liver cells, so Hibsago aims for a functional cure: stopping symptoms and treating the infection without fully eradicating it.

January 2013

Mipomersen and the commercial limits of antisense drugs (2013)

The FDA approved Kynamro (mipomersen), an antisense oligonucleotide for an inherited high-cholesterol condition. It was the second antisense drug to reach the US market.

Then

Sales stayed tiny because the patient pool was small, the drug carried a boxed warning for liver toxicity, and it required injection.

Now

The drug largely failed commercially, showing that a modality's technical success does not guarantee market success.

Why this matters now

Hibsago is also an antisense oligonucleotide. Mipomersen's fate shows how safety warnings and narrow prescribing can limit an approved drug, the same risk analysts flag for Hibsago.

Sources

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