Tyzeka is a product of a commercialization agreement between Novartis and Idenix established in May 2003.
Tyzeka rapidly and profoundly suppresses the hepatitis B virus in adult patients with evidence of viral replication and either evidence of persistent elevations in serum aminotransferases or histologically active disease.
“The FDA approval of Tyzeka is a major milestone for Idenix as it is the first Idenix drug to receive US approval,” said Jean-Pierre Sommadossi, chairman and CEO at Idenix Pharmaceuticals.
“Tyzeka's ability to provide rapid viral suppression in the first 24 weeks of treatment, along with its safety and tolerability profile, make it a promising treatment option for appropriate patients,” said Adrian Di Bisceglie, co-director, Saint Louis University Liver Center.
In clinical studies Tyzeka was generally well tolerated. Most common adverse effects were muscle weakness, upper respiratory tract infection, fatigue, headache, abdominal pain and cough.