First Approval For Oral Hepatitis B Drug

Glaxo Wellcome's Zeffix (lamivudine) has received its first worldapproval, in the Philippines, for the treatment of chronic hepatitis B virus infection. The drug also becomes the first oral treatment to be registered for HBV. Launch of the product is scheduled for October, but no pricing details are yet available.

GW said it had filed the product first in the Philippines "in order to make Zeffix available as early as possible in those countries with the greatest disease burden." The filing in the Philippines was made in July last year, followed by applications in China and Japan. Zeffix has now been filed in the major Asia-Pacific markets as well as in North America and Europe.

The market for lamivudine in HBV is expected to be large, as there are around 350 million long-term carriers of HBV worldwide, of which 75% are located in the Asia-Pacific region. The established therapy is injections with interferon alfa three times a week over six months, so a once-daily oral alternative will be popular. Goldman Sachs analysts have predicted 2003 sales of L520 million ($840 million).