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Article: FDA clears Xoma/Genentech's Raptiva as plaque psoriasis therapy in adults.
- Article from:
- Pharma Marketletter
- Article date:
- November 3, 2003
CopyrightCOPYRIGHT 2003 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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The US Food and Drug Administration has approved the use of Xoma/Genentech's Raptiva (efalizumab) in the treatment of chronic moderate-to-severe plaque psoriasis in adults aged 18 or older who are candidates for systemic therapy or phototherapy.
The decision follows the recent unanimous recommendation for approval of the agent by the FDA's Dermatologic and Ophthalmic Drug Advisory Committee (Marketletter September 15).
Clinical findings
The Biologics License Application submitted to the FDA in December 2002, with a supplemental data amendment filing in May this year, contains results from more than 2,700 patients treated with Raptiva, including ...