|
|
Article: Millennium & ILEX Partners Receive Complete Response Letter From FDA for CAMPATH -alemtuzumab-; Timeframe Extended for Final Agreement On Labeling and Confirmatory Study.
- Article from:
- Business Wire
- Article date:
- February 21, 2001
CopyrightCOPYRIGHT 2001 Business Wire. 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)
|
Business Editors and Health/Medical Writers
CAMBRIDGE, Mass. and SAN ANTONIO--(BUSINESS WIRE)--Feb. 21, 2001
Millennium & ILEX Partners, L.P., a joint venture of Millennium Pharmaceuticals Inc. (Nasdaq:MLNM) and ILEX(TM) Oncology Inc. (Nasdaq:ILXO), today announced the receipt of a Class 1 complete response letter from the Food and Drug Administration (FDA).
The letter concerns the partnership's Biologics License Application (BLA) for the CAMPATH(R)(alemtuzumab) investigational humanized monoclonal antibody. The drug received a recommendation for accelerated approval for patients with chronic lymphocytic leukemia who have been treated with ...