Novartis Pharmaceuticals and Idenix submit Hepatitis B treatment to FDA

Novartis Pharmaceuticals and Idenix Pharmaceuticals have jointly submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for the chronic hepatitis B treatment telbivudine.

Novartis, through its affiliate Novartis Pharma AG, is expected to make further applications in the European Union and key Asian markets in the first quarter of this year.

Idenix chairman and CEO Jean-Pierre Sommadossi said: “Idenix is pleased to be submitting its first NDA for an agent that has the potential to provide a new treatment option for the millions of chronic hepatitis B patients around the world.

“The submission of this application in just seven years from discovery of the use of telbivudine for the treatment of hepatitis B highlights the expertise and execution capabilities of our team and the impact of our alliance with Novartis.

“This marks a significant step in our company’s growth and in the pursuit of our goal of building a leading antiviral franchise.”

Chronic hepatitis B is thought to affect around 350 million people worldwide and be responsible for up to 80 per cent of the world’s primary liver cancer.

An Idenix spokesman explained that although treatments for chronic hepatitis B are available, there remains a need for drugs that provide improved response rates, better-long-term efficacy, reduced rates of drug resistance, improved safety and tolerability, and more convenient dosing regimens.

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