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news.Idenix Pharmaceuticals has said that its hepatitis B drug Sebivo has received approval in China as a once-a-day treatment.
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Hepatitis B remains a significant global health care concern, particularly in China where it affects more than 100 million people. Sebivo, generic name telbivudine, is expected to be available in China in April.
“Now, Chinese patients may also benefit from telbivudine’s ability to provide early viral suppression, a primary goal of treatment,” said Dr Calvin Pan, director, Clinical Research/Hepatology, Mount Sinai Services at Elmhurst Hospital in New York City.
Telbivudine received regulatory approval in the US from the FDA in October 2006 for the treatment of hepatitis B in adult patients with evidence of viral replication and active liver disease. Telbivudine is called Tyzeka in the US and is called Sebivo in all other countries.
A recent study demonstrated that telbivudine provided potent viral suppression and high rates of PCR-negativity after one year. An additional Chinese phase III trial, involving 332 adult Chinese patients, corroborated these findings and supplemented the filing in China.
Idenix and Novartis Pharma are co-promoting telbivudine in the US, France, Germany, Italy, Spain and UK, under a development and commercialization arrangement established in May 2003.