US regulators have fast-tracked GSK’s treatment for hepatitis B.
In a boost for pharma giant and FTSE 100 boss Emma Walmsley, Bepirovirsen is likely to hit the market sooner.
The Food and Drug Administration (FDA) moved the treatment to the fast track following a request from GSK that the drug should be fast-tracked through the review process to “address an unmet medical need.”
Chronic hepatitis B (CHB), which affects around 300 million people worldwide, is a viral infection of the liver that can sometimes be asymptomatic.
But if left untreated, it can cause liver damage and increase the risk of cancer.
Medical necessity: Hepatitis B treatment Bepirovirsen is likely to come to market sooner following a request from GSK for it to be fast-tracked through the review process.
GSK said treatment options for CHB did not offer a significant cure rate, which is defined as reducing the presence of the virus in the body to undetectable levels, meaning the immune system can control it without further medication.
He added that Bepirovirsen, however, was the only treatment in late-stage clinical trials that had shown potential to achieve a “clinically significant functional cure response” when combined with existing antiviral drugs.
The accelerated review of its hepatitis B treatment is another shot in the arm for GSK following strong results last month, which allowed it to improve its growth forecasts.
The company saw sales rise 5 per cent last year to £30.3bn and operating profit hit £8.8bn, an increase of 12 per cent compared to the previous year.
GSK’s sales have been boosted by Arexvy, its respiratory syncytial virus (RSV) vaccine, which achieved blockbuster status last year after raising more than £1 billion in revenue.
GSK has also benefited from growing demand for its cancer drugs, with the division reporting a 20 per cent sales rise last year to £731 million.