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MDX-010 receives orphan drug designation.
2004 JUL 7 - (NewsRx.com & NewsRx.net) -- Medarex, Inc., (MEDX) announced that under the U.S. Orphan Drug Act, the U.S Food and Drug Administration (FDA) has granted orphan drug designation to Medarex's fully human anti-CTLA-4 antibody, MDX-010, for the treatment of high-risk stage II, stage III, and stage IV melanoma.
Orphan designation is granted for treatments that offer potential therapeutic value for diseases that affect fewer than 200,000 people in the U.S. Orphan drug designation also provides eligibility for a special 7-year period of market exclusivity upon approval, potential tax credits for research, grant funding for research and development, reduced filing fees for marketing applications, and assistance with the review of clinical trial protocols.
Pending approval of a special protocol assessment application that has been filed with the FDA, Medarex expects to initiate a pivotal study for MDX-010 in combination with a gp100 melanoma vaccine in the second half of 2004.
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