GSK announced on Monday that it had been granted "fast track" approval by the FDA, the US health authority, for its experimental treatment for chronic hepatitis B.

The British company said that the FDA's decision was based on data from Phase IIb clinical trials, to be confirmed by a Phase III study currently underway.

Bepirovirsen is designed to recognize and destroy the genetic components (i.e. RNA) of the hepatitis B virus that can lead to chronic disease, enabling patients' immune systems to 'regain control'.

It inhibits viral DNA replication in the body and stimulates the immune system to increase the chances of a sustained, long-lasting response.

The compound was originally discovered by Ionis Pharmaceuticals, with whom GSK has entered into a licensing agreement in 2019.

According to the biopharmaceutical group, chronic hepatitis B affects some 300 million people worldwide.

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