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Gilead’s Vemlidy Hep B Drug Approved In EU (GILD)

Gilead Sciences Inc. (GILD) secured marketing authorization from the European Commission for its hepatitis B drug Vemlidy. The oral medicine will be available in once-daily tablets of 25 mg, and will be suitable for adults and adolescents (aged 12 years and older with body weight at least 35 kg).

 

The EU approval paves the way for marketing of Vemlidy in the 28 countries of the European Union, Norway and Iceland.

The drug received a positive opinion in November 2016 from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA). (For more, see Gilead Hepatitis B Drug Gets European Nod.)

 

It was already approved by the U.S. Food And Drug Administration (FDA) in early November. (For more, see Gilead Gets FDA OK for Hepatitis B Drug.)

Improved Hep B Medication

 

The Foster City, California-based company already has an existing hepatitis B medicine called Viread (tenofovir disoproxil fumarate, TDF) 245 mg, which is approved in the U.S. and Europe.

 

Gilead's new drug, Vemlidy, is more efficient and better for bone and liver safety than Viread, as it more efficiently delivers tenofovir to liver cells called hepatocytes.

Vemlidy also requires lower doses, around one-tenth of a standard Viread dose. The lower dose limits the amount of tenofovir reaching the bloodstream, which fares better on renal and bone laboratory safety parameters.

 

An estimated 13.3 million people in the Europe are affected with chronic hepatitis B, representing 1.8% of the adult population. It causes more than 36,000 deaths each year.

Gilead plans to make Vemlidy available in Europe as soon as possible, as it looks forward to new sources of revenue from the large European market. Amid declining sales of its Hepatitis C Virus drugs, the company is focusing on NASH and HIV therapies in 2017.

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