Swiss drugmaker, Roche, moved a step closer to bringing the first long-acting interferon alpha product to the European Union’s chronic hepatitis B market after its Pegasys (peginterferon alfa-2a) drug was backed by the European Commission’s advisory board, the CHMP.
The positive opinion from the CHMP must still be ratified by the Commission but makes it likely that Pegasys will become the first pegylated interferon to get approval in the EU for chronic hepatitis B, which affects 350-400 million people around the world, according to World Health Organisation estimates. It has already been cleared for this indication in Switzerland, Taiwan and Thailand, and US approval is expected next year.
The hepatitis B drug market is now dominated by two antivirals, GlaxoSmithKline’s Zeffix (lamivudine) and Gilead’s Hepsera (adefovir dipivoxol). The former tends to be used for first-line therapy as it is substantially cheaper than Hepsera, which is commonly reserved for second-line therapy following the development of resistance to Zeffix; this can occur in up to 67% of patients, according to a recent report published by Datamonitor.
Roche now maintains that Pegasys should be the drug of choice for first-line use in chronic hepatitis B, because clinical tries show it is superior to lamivudine in achieving a sustained patient response.
Pegasys’ rival in the pegylated interferon alpha category – Schering-Plough’s PegIntron (peginterferon alfa-2b) – is also being developed for chronic hepatitis B and earlier this month was shown to be effective in a study published in The Lancet (January 8). But S-P is still trailing Roche in this indication, and also has a narrower set of indications in hepatitis C, now that Pegasys has been approved for patients with normal liver enzyme levels [[12/11/04d]].