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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  Humanized anti-BCMA (B-cell maturation antigen) monoclonal antibody
Trade Name:  BLENREP
Date Designated:  06/22/2017
Orphan Designation:  Treatment of multiple myeloma
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  08/05/2020 
Approved Labeled Indication:  for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent
Exclusivity End Date:     
Exclusivity Protected Indication* :  
GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LTD
980 GREAT WEST ROAD
BRENTFORD, MIDDLESEX TW89GS
United Kingdom

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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