Mapp Biopharmaceutical – the San Diego startup that shot to fame last year when its experimental drug, ZMapp, was used to treat Ebola patients during last year’s outbreak – just received orphan designation from European regulators.
ZMapp already achieved orphan drug status from the Food and Drug Administration last year, and fast-track status just last month. This nod from the European Medicines Agency will help speed up the global approval of this drug, Mapp Biopharmaceutical says.
While Mapp Biopharmaceuticals remains a low-profile company, the impact of its drug was reported widely as it was used to treat U.S. patients infected with Ebola. ZMapp is a cocktail of three antibodies, first identified in January 2014, and has been developed with the support of multiple health agencies around the world.
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“We are hopeful that the Orphan Medicinal Product designation from the EMA will ultimately result in access to ZMapp for those who need it,” CEO Kevin Whaley said in a statement.