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| | | ![]() EU Committee Backs Zeffix For Chronic Hepatitis B LAVAL, Quebec -- April 27, 1999 -- The European Union’s Committee for Proprietary Medicinal Products (CPMP) has given a positive opinion on Zeffix, the world’s first oral antiviral treatment for chronic hepatitis B, recommending its approval in the European Union. Zeffix was developed by BioChem Pharma Inc. and is being marketed by Glaxo Wellcome. The CPMP has recommended the approval of Zeffix for a broad group of chronic hepatitis B patients. The recommendation, which comes under the CPMP’s classification known as "exceptional circumstances", asks that Glaxo Wellcome continues to supply the approval agency with additional data on specific patient sub-groups over the coming years. The European Commission will make a final decision after considering the committee’s opinion. The marketing application for Zeffix was submitted to the European Medicines Evaluation Agency (EMEA) in March 1998 under the centralized procedure, through which a single license is granted for all 15 member states of the European Union. According to World Health Organization data, approximately 350 million people around the world are long-term (chronic) carriers of the hepatitis B virus (HBV), including an estimated four million people in the European Union. Zeffix is available in the Philippines, Hong Kong, Canada (as Heptovir), the USA (as Epivir-HBV), and Switzerland, and approved in China (as Heptodin), Thailand, Pakistan, New Zealand and Argentina. Regulatory applications to market Zeffix for chronic hepatitis B treatment have been submitted worldwide, including in Korea, Taiwan and Japan.
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