Novartis announced the US regulatory approval of Tyzeka (telbivudine) as a new once-a-day oral treatment for patients with chronic hepatitis B, a disease estimated to affect about 1.25 million people in the US but more than 350 million globally and considered the tenth leading cause of death.
Taken with or without food, Tyzeka suppresses the hepatitis B virus (HBV) rapidly and profoundly in adult patients with evidence of viral replication and evidence of either persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
Already available in Switzerland, and now approved by the US Food and Drug Administration, telbivudine will be marketed as Sebivo outside the US. It has also been submitted for regulatory approval with the European Medicines Agency (EMEA) and the Chinese health authority in the first quarter of 2006.
"Profound suppression of the hepatitis B virus is associated with improved outcomes and is a primary treatment goal," said Dr. Adrian M. Di Bisceglie, MD, Professor of Medicine and Chief of Hepatology, Division of Gastroenterology and Hepatology, at St. Louis University, and Co-director, St. Louis University Liver Center, US.
"Tyzeka's ability to provide rapid viral suppression in the first 24 weeks of treatment, along with its demonstrated safety and tolerability profile, make it a promising treatment option for patients," Dr. Di Bisceglie said.
Approximately 1.25 million people in the US are living with chronic hepatitis B, a virus that infects the liver and is 50 to 100 times more infectious than HIV1. Chronic hepatitis B is estimated to affect approximately 350 million people worldwide1 and is the tenth leading cause of death worldwide, responsible for up to 1.2 million deaths each year.
"Novartis is committed to infectious diseases and the development of new therapies in the treatment of hepatitis," said Giacomo di Nepi, Head of Infectious Diseases, Transplantation and Immunology at Novartis Pharma AG. "The approval of Tyzeka demonstrates our dedication to provide additional treatment options to patients with chronic hepatitis B and physicians."
Tyzeka is being developed in collaboration between Idenix and Novartis Pharma AG under a development and commercialization arrangement established in May 2003. Idenix is also developing valtorcitabine, another hepatitis B compound, and valopicitabine, a hepatitis C compound, in collaboration with Novartis. Under this agreement, Novartis and Idenix will co-promote telbivudine, valtorcitabine and valopicitabine in the United States, France, Germany, Italy, Spain and the United Kingdom. Novartis has the exclusive right to commercialize telbivudine, valtorcitabine and valopicitabine in the rest of the world.
Novartis is committed to infectious diseases and is developing a portfolio of complementary mechanisms of action in the treatment of hepatitis B and C, while working to bring innovation for serious hospital infections.