Novartis AG has received major important approval from Switzerland for Sebivo (telbivudine), a new treatment for patients with chronic hepatitis B. Sebivo shown to deliver more rapid and profound viral suppression than lamivudine.
This important approval provides access to an innovative new therapy for Swiss patients but also supports expanded regulatory submissions. More than 100 countries worldwide look to the approval of a medicine in the company's home country to serve as a reference for local regulatory reviews. A single pill taken orally once daily with or without food, Sebivo has been shown to effectively suppress replication of the hepatitis B virus.
Approximately 350 million people worldwide are living with chronic hepatitis B, a virus that affects the liver and is estimated to be 50 to 100 times more infectious than human immunodeficiency virus (HIV). Hepatitis B virus can cause chronic lifelong infection, which can lead to several liver conditions including cirrhosis (scarring), cancer or organ failure and death. Hepatitis B is the second most common cause of cancer after smoking, with 1.2 million people estimated to die annually from hepatitis B-related chronic liver disease.
"We are committed to helping physicians offer better care for patients with chronic hepatitis B, and the approval of Sebivo in Switzerland is a significant step toward achieving this goal," said Giacomo di Nepi, Head of the Infectious Diseases, Transplantation and Immunology Business Unit at Novartis Pharma AG. "This approval not only makes Sebivo available in Switzerland but also supports approvals in many countries that first require Swiss approval."
Applications for approval were filed with the US Food and Drug Administration (FDA) in late 2005 as well as with the European Medicines Agency (EMEA) and the Chinese health authority in the first quarter of 2006. A different trademark for telbivudine in the US is currently under discussion.
Sebivo is being developed in collaboration between Idenix Pharmaceuticals, Inc. and Novartis Pharma AG under a development and commercialization arrangement established in May 2003, along with another hepatitis B clinical product candidate, valtorcitabine.
The collaboration arrangement further provides that Idenix and Novartis will co-promote Sebivo and valtorcitabine and other product candidates that Novartis has licensed, upon successful development and approval, in the US, France, Germany, Italy, Spain and the UK.
Novartis holds the exclusive license to commercialize Sebivo and valtorcitabine in the rest of the world. In March 2006, Novartis expanded its collaboration with Idenix to include valopicitabine for the treatment of chronic hepatitis C.