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Article: Approval of Xoma/Genentech's Raptiva still on track after backing by FDA panel.
- Article from:
- Pharma Marketletter
- Article date:
- September 15, 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's Dermatologic and Ophthalmic Drug Advisory Committee has voted unanimously (11-0) to recommend the approval of Raptiva (efalizumab) for the treatment of moderate-to-severe plaque psoriasis in adults aged 18 or over. The FDA typically follows the recommendations of its advisory panels and the drug's developers, Genentech and Xoma, expect a final decision from the FDA by October 27.
The Biologics License Application was submitted to the FDA in December 2002, with a supplemental data amendment filing in May this year. Raptiva is being developed by Genentech and Xoma in the USA, whilst Serono has licensed the worldwide rights to ...