Novartis' Sebivo gains domestic approval

Swiss drug major Novartis' Sebivo (telbivudine), a new treatment for patients with chronic hepatitis B, has been cleared in Switzerland. According to the firm, the approval of the drug, which has been shown to deliver more rapid and profound viral suppression than the potent reverse transcriptase inhibitor lamivudine, supports expanded submissions as more than 100 countries worldwide look to the approval of a medicine in the company's home country as a reference for local regulatory reviews.

The firm noted that Sebivo is a single pill taken orally once daily, with or without food, that has been shown to effectively suppress replication of the hepatitis B virus, which affects the liver and is estimated to be 50 to 100 times more infectious than HIV. Approximately 350 million people worldwide are living with the infection which is the second most common cause of cancer after smoking. 1.2 million people die annually from HBV-related liver disease.

The approval of Sebivo is based primarily on one-year data from the GLOBE study, the largest worldwide registration trial ever conducted in patients with chronic hepatitis B. This two-year Phase III clinical trial compared Sebivo with lamivudine in the treatment of 1,367 adults with chronic hepatitis B at 112 clinical centers in 20 countries. Novartis noted that further applications for approval were filed with the US Food and Drug Administration in late 2005 as well as with the European Medicines Agency (EMEA) and the Chinese State Food and Drug Authority in the first quarter of the year. A different trade mark for the agent in the USA is currently under discussion.