GSK receives fast-track status for drug against chronic hepatitis B

GSK receives fast-track status for drug against chronic hepatitis B

Pharmaceutical giant GSK has received special recognition from the US Food and Drug Administration (FDA) for its drug bepirovirsen.

Pharmaceutical giant GSK has received special recognition from the US Food and Drug Administration (FDA) for its drug bepirovirsen.

Pharmaceutical giant GSK has received special recognition from the U.S. Food and Drug Administration (FDA) for its drug bepirovirsen for the treatment of chronic hepatitis B (CHB).

This recognition, known as Fast Track designation, is given to medicines intended for the treatment of serious diseases and that meet an urgent medical need.

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

The success rate of existing treatments for CHB, which affects about 300 million people worldwide, is low. There is no permanent need for drugs to achieve immunity to the virus.

The news followed a series of other positive treatment updates from the pharmaceutical 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 drug Blenrep.

The group also announced last week that Chinese drug regulators had approved its application for approval of Shingrix to prevent shingles in at-risk adults aged 18 years and older, potentially opening up a new market for its flagship product Shingrix.

In January, the biotech company revised upward its growth forecast for the coming years after reporting a five percent increase in sales to £30 billion in 2023 as a result of strong vaccine sales.

At the end of last year, GSK also launched a vaccine against respiratory syncytial virus (RSV), which can cause serious harm to infants and older adults.

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