Friday, 16 October 2015

ZMapp™ Granted Orphan Medicinal Product Designation by the EMA



LeafBio, Inc., the commercial arm of Mapp Biopharmaceutical, Inc., announced today that the European Medicines Agency (EMA) has granted ZMappTM “Orphan Medicinal Product Designation.” The designation is granted by the EMA to encourage development of drugs and other products targeted at rare diseases that have no cure or treatment. The status allows for certain benefits, including protocol assistance and market exclusivity. Mapp Biopharmaceutical has been working to develop a therapy to treat Ebola virus for more than a decade.
“The Orphan Medicinal Product designation by the European Medicines Agency is another crucial step toward approval of ZMapp™. We are gratified by the EMA’s designation, and remain committed to finding a successful treatment for this deadly disease,” said Dr. Larry Zeitlin, President of LeafBio and Mapp.
ZMapp™ is a cocktail comprised of three antibodies intended to fight Ebola virus and was identified in January 2014. Its development was supported by health agencies around the world.
“We are hopeful that the Orphan Medicinal Product designation from the EMA will ultimately result in access to ZMapp™ for those who need it,” added Dr. Kevin Whaley, CEO of LeafBio and Mapp.
ZMapp™ had been granted orphan drug status by the U.S. Food and Drug Administration in August 2014 and achieved FDA “Fast Track” status in September 2015. ZMapp™ was used last summer to treat patients in Europe who were diagnosed with the Ebola virus. This designation by the EMA does not affect the ZMappTM clinical trial currently taking place in West Africa.

Posted by Tim Sandle

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