GSK receives Fast Track designation for chronic hepatitis B drug in latest boost for pharma giant

Pharmaceutical giant GSK has received special recognition from the US Food and Drug Administration (FDA) for its bepirovirsen drug, used to treat chronic hepatitis B (CHB).

This recognition, called the Fast Track designation, is given to drugs that address serious conditions and fulfil an urgent medical need.

Bepirovirsen has shown “positive results” in trials with the “potential to achieve clinically meaningful” responses when combined with other antiviral therapies, meaning the virus could be controlled by the immune system alone.

Existing treatments for CHB, which affects around 300m people worldwide, have a low success rate in achieving immunity from the virus without a consistent need for medication.

The news followed a string of other positive treatment updates from the pharma giant.

GSK, formerly known as Glaxosmithkline, last week announced a potential breakthrough in the treatment of relapsed or refractory multiple myeloma, a type of blood cancer, with its Blenrep drug.

The group also announced last week that China’s drug regulators had accepted its regulatory application for Shingrix for the prevention of shingles in at-risk adults aged 18 and over, potentially opening up a new market for the flagship Shingrix product.

In January, the biotech company upgraded its growth outlook for the years ahead after delivering a five per cent increase in sales in 2023 to £30bn, driven by strong vaccine sales.

Late last year, GSK also launched a vaccine for respiratory syncytial virus (RSV), which can badly affect babies and older adults.