New drug application for Pegasys filed in Japan

Published: 12-Dec-2002

Pegasys is expected to be the first pegylated interferon to become available in Japan - the world's second largest hepatitis C market - following the filing of a new drug application (NDA) with the Japanese health authorities by Chugai Pharmaceutical Co., a member of the Roche Group.


Pegasys is expected to be the first pegylated interferon to become available in Japan - the world's second largest hepatitis C market - following the filing of a new drug application (NDA) with the Japanese health authorities by Chugai Pharmaceutical Co., a member of the Roche Group.

The NDA is for Pegasys monotherapy, (peginterferon α-2a) to treat chronic hepatitis C in adults.

In a local phase II clinical study in Japan, patients receiving 180µg Pegasys once weekly showed higher sustained virological response rates compared with three times weekly conventional interferon therapy. Flu-like symptoms, a common side effect seen with interferon therapy, occurred less frequently with once weekly Pegasys.

Pegasys has been approved in more than 50 countries worldwide, with the most recent approval by the US FDA for the combination of Pegasys and Copegus, Roche's own ribavirin.

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