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Article: Genentech, XOMA Come Through With Strong Phase III Raptiva Data.
- Article from:
- BIOWORLD Today
- Article date:
- November 4, 2009
CopyrightCOPYRIGHT 2009 A Thomson Healthcare Company. 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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Senior Staff Writer
When trying to get a drug approved, biotechnology companies must provide the FDA with data - data showing that a drug is efficacious, that it works in the appropriate patient and that it is safe, among other things.
Genentech Inc. and partner XOMA Ltd. also had to provide data showing their psoriasis drug, Raptiva, has the same effect on patients when made with material produced by either one of the partners. A completed Phase III trial disclosed Tuesday seems to have done just that, potentially removing the final obstacle for a biologics license application filing by year's end.
"We view this as the last stumbling block," ...