Roche was cheered Friday after the US Food and Drug Administration gave a green light to its big-selling antiviral drug Pegasys (pegylated interferon alfa-2a) in the treatment of hepatitis B. Pegasys is the only drug of its class to receive a label in this indication – a condition for which it is already approved in Europe [[24/01/05e]] - allowing it to steal a march on rivals and secure a larger slice of the hepatitis market.
The Centers for Disease Control estimates that 1.25 million people in the USA alone are chronically infected with hepatitis B, a virus that can lead to cirrhosis, liver cancer and even death. Pegasys was first approved in the USA three years ago for use in chronic hepatitis C [[17/10/02a]], and earlier in 2005 secured an important new win in treating patients co-infected with hepatitis C and HIV [[28/02/05c]].
During the first quarter, sales of the product jumped 15% to 325 million Swiss francs [[19/04/05b]], and look set to climb even further with this new label. The hepatitis B drug market is currently dominated by two antivirals, GlaxoSmithKline’s Zeffix (lamivudine) and Gilead’s Hepsera (adefovir dipivoxol), while Schering-Plough is also evaluating its hepatitis C offering, PegIntron (peginterferon alfa-2b), for hepatitis B, but is trailing some way behind.