Novartis: Hepatitis B drug’s Swiss approval ‘an important reference’

Novartis has said that Switzerland’s decision to approve Sebivo, a new treatment for the hepatitis B virus, will serve as a reference for other countries currently in the process of reviewing the drug.

The Swiss regulator’s decision to approve the drug was based on clinical trial results that showed that therapeutic response was “significantly” higher than for Sebivo patients than for those taking lamivudine in patients with detectable hepatitis B e-antigen.

Additionally, Sebivo patients demonstrated less treatment failure, less viral resistance and fewer “flares” of serum liver disease markers than patients receiving lamivudine, marketed by GlaxoSmithKline (GSK) as Epivir.

Giacomo di Nepi, head of the infectious diseases, transplantation and immunology business unit at Novartis, stated: “This approval not only makes Sebivo available in Switzerland but also supports approvals in many countries that first require Swiss approval.”

Novartis states that it filed Sebivo with the European Medicines Agency in the first quarter of 2006, as well as with the Chinese health authorities. Application for approval from the US Food and Drug Administration began late in 2005.

The drug will compete against GSK’s Epivir and Bristol-Myers Squibb’s Baraclude, which was launched in the UK earlier this week.