Regulatory

Europe drops liver biopsy for Schering-Plough's PegIntron

Last Updated: 2003-10-21 11:22:12 -0400 (Reuters Health)

LONDON (Reuters) - U.S. drug firm Schering-Plough Corp said in Tuesday that European regulators had changed the label for its PegIntron hepatitis C drug, so that patients would no longer require a liver biopsy.

A spokesman for the London-based European Medicines Evaluation Agency said the move brought PegIntron into line with Roche Holding AG's rival Pegasys product, for which the biopsy requirement was dropped in July.

Traditionally, liver biopsy has been used during treatment to determine disease status. But the new European regulations state a biopsy may not be necessary if a decision to treat has already been made based on other factors.

PegIntron and Roche's newer medicine Pegasys are currently locked in a fierce marketing battle on both sides of the Atlantic. Dropping the requirement for a liver biopsy is likely to increase uptake of the injectable interferon-based therapies, doctors believe.

Chronic hepatitis C, which is estimated to affect more than 10 million people in major world markets, is a leading cause of chronic liver disease and one of the most common reasons for liver transplant.