GSK’s Hepatitis B Drug Bepirovirsen Receives FDA Fast Track Designation

Pharmaceutical giant GSK has earned special recognition from the U.S. Food and Drug Administration (FDA) for its drug bepirovirsen, which is designed to treat chronic hepatitis B (CHB). The drug has been granted Fast Track designation, a status reserved for treatments that address serious conditions and meet an urgent medical need.

Bepirovirsen has demonstrated "positive results" in clinical trials, showing the potential to achieve "clinically meaningful" responses when used in combination with other antiviral therapies. This suggests the possibility of controlling the hepatitis B virus through the immune system without the need for ongoing medication, a significant improvement over current treatments, which have limited success in achieving immunity.

This recognition follows a series of other promising developments for GSK. Last week, the company announced a potential breakthrough in treating relapsed or refractory multiple myeloma, a form of blood cancer, with its Blenrep drug. Additionally, Chinese regulators recently accepted GSK's application for Shingrix, a shingles vaccine for at-risk adults aged 18 and over, potentially expanding the market for this key product.

Earlier this year, GSK raised its growth outlook following a 5% increase in sales in 2023, reaching £30 billion, largely driven by strong vaccine performance. The company also launched a respiratory syncytial virus (RSV) vaccine late last year, targeting vulnerable populations like infants and older adults.