Gilead Sciences receives EU approval for hepatitis B drug Vemlidy

Gilead Sciences has announced that its new hepatitis B drug Vemlidy has been approved by the European Commission.

The regulator has granted marketing authorisation for the once-daily tablet, which is designed for the treatment of chronic hepatitis B virus infections in adults and adolescents. This is the first new treatment for this disease to be approved in Europe in nearly a decade.

This tenofovir alafenamide-based treatment has demonstrated antiviral efficacy similar to Gilead's established therapy Viread, but at one-tenth the dose. The new therapy also offers greater plasma stability, more efficiently delivering tenofovir to hepatocytes, while leaving less tenofovir in the bloodstream.

As such, it has been shown to offer improved renal and bone laboratory safety parameters compared to Viread in clinical trials.

Dr Norbert Bischofberger, executive vice president for research and development and chief scientific officer at Gilead Sciences, said the drug "reflects Gilead's ongoing commitment to improve and simplify care for people with chronic infectious diseases, including hepatitis B, while we continue our research efforts for curative treatments".

This comes after the drug was approved by the US Food and Drug Administration in November and by the Japanese Ministry of Health, Labour and Welfare in December.

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