Glaxo boosted after US regulators fast-track hepatitis B drug Bepirovirsen

GSK’s treatment for hepatitis B has been placed on a fast-track schedule by regulators in the US.

In a boost for the FTSE 100 pharma giant and boss Emma Walmsley, Bepirovirsen is likely to reach the market sooner.

The Food and Drug Administration (FDA) moved the treatment onto the expedited track following a request from GSK that the drug should be accelerated through the review process to ‘address an unmet medical need’.

Affecting around 300m worldwide, Chronic Hepatitis B (CHB) is a viral liver infection which can sometimes be symptomless. 

But if left untreated it can cause liver damage and increase the risk of cancer.

Medical need: Hepatitis B treatment Bepirovirsen is likely to reach the market sooner following a request from GSK that it should be accelerated through the review process 

GSK said treatment options for CHB did not offer a meaningful cure rate, which is defined as reducing the presence of the virus in the body to undetectable levels, meaning it can be controlled by the immune system without further medication. 

It added that Bepirovirsen, however, was the only treatment in late-stage clinical trials that had shown potential to achieve ‘clinically meaningful 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 saw it upgrade its growth forecasts.

The firm saw its sales rise 5 per cent last year to £30.3billion and operating profit hit £8.8billion, a 12 per cent jump compared to the previous year. 

GSK’s sales have been boosted by Arexvy, its vaccine for respiratory syncytial virus (RSV), which achieved blockbuster status last year after raking in over £1billion in revenues.

GSK has also benefited from surging demand for its cancer drugs, with the division reporting a 20 per cent sales increase last year to £731million.

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