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.
“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.