Novartis’ hepatitis B drug gains “major milestone”

Novartis has said that its hepatitis B drug produced in conjunction with Idenix has achieved a “major milestone”.

Tyzeka, a once-a-day oral treatment for hepatitis B virus patients, was recently filed for approval in Europe. Manufacturers say the drug suppresses the virus in adult patients with evidence of viral replication and evidence of persistent elevations in serum aminotransferases or in diseases that are histologically active.

Today’s announcement that the drug has been approved by the FDA for US treatment has been described by manufacturers a “major milestone”, especially given the fact that it has been approved “just six years” after entering clinical development.

Adrian M Di Bisceglie, managing director, professor of medicine and chief of hepatology at Saint Louis University, commented: “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.”

Latest data from a phase III clinical trial into the drug showed its therapeutic response in HBeAg-positive either improved liver disease markers or loss of detectable hepatitis B e-antigen among patients was 75 per cent in comparison with lamivudine.

Nathaniel Brown, managing director of Idenix further commented that approval of Tyzeka is based primarily on the phase III study.

Dr James Shannon recently commented on submission of the drug for European approval. He said that the filing was a “significant step” in making the treatment available to over three million patients.

Hepatitis B virus is the most common liver infection in the world and is known to lead to liver failure, cirrhosis, liver cancer and death.