Approval of Clevudine for the Treatment of Chronic Hepatitis B in the Philippines
HI-Eisai Pharmaceutical Inc. (Headquarters: Makati City, the Philippines, President: Lourdes Magno), a subsidiary in the Philippines of Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito), announced today that the Bureau of Food and Drugs (BFAD) approved “Clevudine” (generic name) for the inhibition of virus replication in chronic hepatitis B patients (HbeAg positive or HbeAg negative) with evidence of active viral replication and elevations in serum aminotransferases (ALT or AST). Eisai will market the drug under a brand name of “REVOVIR” in the Philippines.
Clevudine is an antiviral drug with an inhibitory effect on DNA polymerase for the treatment of chronic hepatitis B. In the Philippines, about 8 million people are believed to be infected with hepatitis B. With its potent and sustained anti-viral effect, Clevudine is expected to be a new treatment option for patients with deterioration in liver function caused by hepatitis B.
Eisai obtained exclusive right to develop, manufacture and market Clevudine in eight Asian countries including China from Bukwang Pharma, a South Korean pharmaceutical company, and has been developing Clevudine in those countries. The Philippines is the first country among them to approve Clevudine for marketing. Eisai is currently expediting the development or proceeding with the preparations for filing for approval of Clevudine in the remainder of the countries.
Eisai develops and markets drugs for liver diseases that include Stronger Neo-Minophagen C®, Glycyron® and Livact® in China and other Asian countries. Eisai will continue to make further contributions to improving QOL and benefits to patients with liver diseases in Asia.
Eisai Co., Ltd.
< Notes to Editors >
• About HI-Eisai Pharmaceutical Inc.
• About Clevudine
Clevudine is an antiviral drug developed for the treatment of hepatitis B. It exerts its anti-HBV effect by inhibiting DNA polymerase, which is necessary for the virus to be replicated. It is also believed to decrease ccc DNA (covalently closed circular DNA, which is a template DNA for viral replication) in the liver cells. Potent and sustained anti-HBV effect of Clevudine is attributed to these mechanisms of action.
Clevudine was also approved in South Korea back in 2006 and is currently being marketed by Bukwang Pharma.
• Eisai Licensed Territories for Clevudine
China, Philippines, India, Indonesia, Malaysia, Singapore, Thailand, Vietnam.