Novartis has announced the Chinese regulatory approval of Sebivo (telbivudine) as a treatment for chronic hepatitis B, a disease estimated to affect more than 100 million people in China and considered the second leading cause of death in the country. The decision comes shortly after Sebivo was recommended for approval in the European Union.
Sebivo meets an urgent demand for effective therapies that can provide profound and sustained suppression of the hepatitis B virus, reducing the risk of liver disease and improving long-term outcomes for patients. Sebivo will be available in China in April.
The need for new therapies is especially pressing in China, where an estimated 10 per cent of the population suffer from chronic hepatitis B. The number of infected people in China represents about one-third of those with the disease worldwide. Despite existing treatments, nearly half a million people in mainland China die each year from liver damage and liver cancer caused by chronic hepatitis B.
"Chronic hepatitis B is a major health problem in China, and through treatment, we aim to prevent the progression of the disease by getting the viral load to as low a level as possible," said Prof Jidong Jia, director of the Liver Research Centre, Beijing Friendship Hospital, Capital Medical University, China. "Sebivo's demonstrated ability to rapidly and profoundly drive down virus levels within the first 24 weeks of treatment, in addition to its favourable safety profile, make it a promising treatment option for patients with chronic hepatitis B."
Worldwide regulatory submissions have been based primarily on one-year data from the GLOBE study, the largest worldwide registration trial ever conducted in patients with chronic hepatitis B and the first to include patients from mainland China. The study results demonstrated that Sebivo provided greater viral suppression and significantly greater response on all virologic markers after one year compared to lamivudine, the most widely prescribed treatment. An additional Chinese phase III trial corroborated these findings and supplemented the filing in China.
"The approval of Sebivo in China represents a milestone in treatment for the millions of patients suffering from chronic hepatitis B," said James Shannon, MD, Global Head of Development at Novartis Pharma AG. "We now look forward to receiving final European Commission approval, and to providing chronic hepatitis B patients in Europe with access to this promising new treatment."
The Committee for Medicinal Products issued the positive opinion in Europe on February 22 for Human Use (CHMP), which reviews drug applications for all 27 countries in the European Union as well as Iceland and Norway. The European Commission generally follows the CHMP's advice and is expected to issue a final decision within two to three months.
Sebivo, a once-daily oral treatment, is already approved in 12 countries including Switzerland and the US, where it is marketed as Tyzeka.