Hepatitis

New hepatitis B indication filed for PEGASYS filed in U.S., E.U. and Switzerland

Published in Clinical Trials Week, August 16th, 2004

Roche announced that it has submitted simultaneous filings for PEGASYS (peginterferon alfa-2a (40KD)) to the regulatory authorities in the U.S., Europe and Switzerland for the treatment for chronic hepatitis B.

If approved, PEGASYS will become the first pegylated interferon indicated for the treatment of chronic hepatitis B, which is the 10th leading cause of death worldwide.

The Swiss authorities, Swissmedic, have already granted PEGASYS 'fast track' review status. The approval in Switzerland would also allow for approvals in approximately 80 other countries that depend on prior Swiss approval.

Roche filed PEGASYS for the...

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Source: Clinical Trials Week (2004-08-16)

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