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European Commission Grants Approval for BARACLUDE(R) (entecavir) for Treatment of Chronic Hepatitis B
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PARIS, June 28 /PRNewswire/ --
Bristol-Myers Squibb announced today that the European Commission has granted an approval for BARACLUDE(R) (entecavir) for the treatment of chronic hepatitis B virus infection.
BARACLUDE(R) is an oral antiviral therapy specifically designed to block the replication of hepatitis B virus (HBV). The medicine, which was discovered and developed in Bristol-Myers Squibb research centers, will be available in some countries in the European Union, the Middle East and Africa beginning in the third quarter of 2006.
BARACLUDE(R) is indicated for use in adults with chronic hepatitis B infection with compensated liver disease and evidence of active viral replication, evidence of persistent elevations of the blood levels of aminotransferases -- a marker for liver disease -- and active liver disease as determined by biopsy.
"Chronic hepatitis B burdens millions of people in our region and we believe BARACLUDE represents an innovative treatment option," said Beatrice Cazala, President, Europe, Middle East and Africa for Bristol-Myers Squibb. "We are focused on finding ways to extend and enhance the lives of chronically-infected hepatitis B patients across the entire region, including Western Europe, but also in other countries with high prevalence such as Turkey, Russia and Greece."
Chronic hepatitis B infection is a potentially life-threatening disease and is a serious global public health issue. More than 2 billion people worldwide have been infected by the virus and about 400 million people worldwide have chronic hepatitis B. In Europe, an estimated 1 million people are infected with hepatitis B each year.
Hepatitis B is the 10th leading cause of death worldwide, causing 1.2 million deaths annually, and chronic hepatitis B infection is the No. 1 cause of hepatocellular carcinoma, a form of liver cancer. The hepatitis B virus is 100 times more infectious than HIV, the virus that causes AIDS.
Measuring the amount of the hepatitis B virus in a person's bloodstream -- also known as the viral load -- can be an important way to predict a person's progression to serious liver disease and liver cancer. Recent studies have shown that among hepatitis B patients who have the highest viral load levels, there is a significantly increased future risk of eventually developing cirrhosis and liver cancer.
"Hepatitis B is a serious disease and it is important for patients and physicians to have potent treatments with good tolerability," said Michael Manns, M.D., Professor, Chairman and Director, Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany. "With the approval of BARACLUDE, we have an important new medication to treat chronic hepatitis B and lower patients' viral load to undetectable levels."
The benefits seen in studies of BARACLUDE(R) relate to its ability to slow the progression of chronic HBV infection. This was shown in three clinical studies in patients naive to previous antiviral treatment and in patients with resistance to lamivudine, another anti-hepatitis B agent, infected by wild type virus (HBeAg positive), pre-core mutant virus (HBeAg negative) and with compensated liver disease.
After 48 weeks of treatment -- or two years for those with only a virological response initially -- patients receiving BARACLUDE(R) achieved greater or similar responses compared to patients receiving lamivudine, with regard to improvement in the liver inflammation and degree of liver fibrosis (scarring) caused by HBV, reduction in the amount of virus in the blood, normalization of liver function and seroconversion. Among nucleoside-naive patients without evidence of lamivudine resistance at baseline, no resistance has emerged through 96 weeks of treatment with BARACLUDE(R). Furthermore, BARACLUDE(R) was well-tolerated, similar to lamivudine.
BARACLUDE(R) has a favorable benefit-risk profile based on the efficacy, resistance and safety data from clinical studies, supporting its use in the treatment of chronic hepatitis B infection in adults.
About BARACLUDE(R) (entecavir)
The global BARACLUDE(R) clinical trial program was the first to compare two antivirals, BARACLUDE(R) and lamivudine (the most commonly used oral antiviral therapy for the treatment of chronic hepatitis B worldwide) and involved over 1,600 patients worldwide. Bristol-Myers Squibb is continuing to evaluate and monitor consenting chronic hepatitis B patients who participated in the BARACLUDE(R) clinical trial program.
Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.
BARACLUDE(R) is a trademark of Bristol-Myers Squibb.
Refer to the BARACLUDE(R) Summary of Product Characteristics for further information or contact Brian Henry, Bristol-Myers Squibb Corporate and Business Communications, at +33-1-58-83-69-38
Brian Henry of Bristol-Myers Squibb, Office: +33-1-58-83-69-38, Mobile: +33-6-75-09-08-99, brian.henry@bms.com
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