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FDA Orphan Drug Designation For Treatment Of Ebola Virus

August 29, 2014






On August 25th, the FDA grants LeafBio Inc’s ZMapp product an Orphan Drug Designation (ODD) for the treatment of the Ebola virus infection:

FDA Orphan Product Designation Database Record

Generic Name: Monoclonal antibody consisting of three mouse/human chimeric IgG1 monoclonal antibodies (c2G4, c4G7, and c13C6) that target Ebola virus
Trade Name: n/a
Date Designated: 08-25-2014
Orphan Designation: Treatment of Ebola virus infection
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Sponsor: LeafBio, Inc. 6160 Lusk Blvd., Suite C105 San Diego , CA 90121


LeafBio Inc., is the commercialization arm of Mapp Biopharmaceutical, a company developing novel pharmaceuticals for the prevention and treatment of infectious diseases. Mapp Biopharmaceutical focuses on unmet needs in global health and biodefense. As Mapp Biopharmaceutical’s products transition to clinical evaluation, LeafBio assumes ownership and commercialization responsibilities.

ZMapp  is the result of a collaboration between:

•   Mapp Biopharmaceutical (San Diego)

•   LeafBio (San Diego)

•   Defyrus Inc. (Canada)

•   U.S. government

•   Public Health Agency of Canada (PHAC).

ZMapp is made up of 3 humanized monoclonal antibodies manufactured in plants, specifically Nicotiana. It is an optimized cocktail that was first identified as a drug candidate in January 2014. ZMapp has not yet been evaluated for safety in humans and very little of the drug is currently available. Because ZMapp is an experimental product, only limited supplies were manufactured for testing in animals. ZMapp has shown efficacy in a monkey model of Ebola.

ZMapp was the experimental anti-viral drug given to American missionaries Kent Brantly and Nancy Writebol, as well as a Spanish priest and 3 African healthcare workers. One of the African healthcare workers died.

Mapp Pharmaceutical has only 9 employees. All of the samples of ZMapp are now gone and the company is looking for help from the federal government to make more. Meanwhile, the National Institutes of Health (NIH) has the go ahead to start testing a new Ebola vaccine in humans, with data maybe being available by the end of 2014. The vaccine is developed by NIH and Okairos, a biotech GlaxoSmithKline acquired in 2013.

Please Note: “Ebola Virus Particles” courtesy of NIH/NIAID [CC-BY-2.0 Generic].

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