Daily Pill Treats Chronic Hepatitis B in Adults

By HospiMedica staff writers
Posted on 21 Mar 2007

A once-a-day tablet for the treatment of chronic hepatitis B infection in adult patients has been recommending for marketing authorization by the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP).

Sebivo (telbivudine) is indicated for the treatment of chronic hepatitis B in adult patients with evidence of viral replication and either evidence of persistent elevations in serum aminotransferases (alanine amino transferase (ALT) or aspartate transaminase (AST)) or a histologically active disease. This indication is based on virologic, serologic, biochemical, and histologic responses after one year of treatment in nucleoside-treatment-naive adult patients with HBeAg-positive and HbeAg-negative chronic hepatitis B with compensated liver disease. In clinical studies, Sebivo was generally well tolerated with most adverse experiences classified as mild or moderate in severity. Sebivo was developed by Idenix Pharmaceuticals (Cambridge, MA, USA), which is promoting it in Europe in collaboration with Novartis Pharma (Basel, Switzerland).

"Chronic hepatitis B is a very serious disease affecting more than 350 million people worldwide and a growing public health problem in Europe,” said Jean-Pierre Sommadossi, Idenix's chairman and CEO. "We are assembling a strong commercial team in Europe and look forward to working with Novartis to make Sebivo available to European patients as soon as possible after it is formally approved.”

The CHMP's recommendations are advisory but the European Commission (EC) has historically followed them and the company expects a final decision to be issued within three months. The positive opinion from CHMP follows earlier approvals in the US, where the drug is being marketed as Tyzeka 600-mg tablets. The drug is also marketed in Canada, Switzerland, and some countries in Asia and Latin America. An application for marketing approval is pending with the Chinese health authority.

Related Links:
Idenix Pharmaceuticals
Novartis Pharma