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Article: Idenix lowers NM283 dosage after AE reports.(Idenix Pharmaceuticals Inc.)(adverse events )(Brief article)
- Article from:
- Pharma Marketletter
- Article date:
- April 3, 2006
CopyrightCOPYRIGHT 2006 Marketletter Publications Ltd. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Idenix Pharmaceuticals, a US biopharmaceutical company focused on viral and other infectious diseases, has modified its ongoing Phase IIb hepatitis C trials of its drug candidate valopicitabine (NM283) due to side effects.
Dosing levels for the investigational antiviral, which is being co-developed by Swiss drug major Novartis, have been reduced from 800mg/day to 200mg/day or 400mg/day as a result of dose-related gastrointestinal adverse events observed in both treatment-naive and treatment-refractory patients on 800mg regimens. The firm noted that its changes have been discussed and agreed with the US Food and Drug Administration.
Idenix stressed that ...
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