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Ebola Drug Receives FDA Fast-Track Designation
The FDA has granted ZMapp (LeafBio) a fast-track designation for the treatment of Ebola virus disease. LeafBio is the commercial arm of Mapp Biopharmaceutical, which has been working to develop a therapy to treat Ebola virus for more than a decade.
Fast-track designation may shorten the path toward filing and obtaining approval of a biologics license application, which must be approved by the FDA before ZMapp may be marketed in the United States. The designation does not affect the ongoing clinical trial of ZMapp taking place in West Africa.
ZMapp was first tested on humans during the Ebola virus outbreak in West Africa in 2014, but it was not subjected to controlled trials to determine its potential. The drug was initially given on an emergency basis to sick health workers evacuated from the region.
The Ebola epidemic is the largest in history, affecting multiple countries in West Africa, according to the Centers for Disease Control and Prevention. The disease has been reported in Liberia, Nigeria, Mali, and Senegal and has killed more than 11,000 people since 2013.
Fast-track designation is granted to drugs that the FDA determines have the potential to address an unmet medical need and that are intended to treat a serious condition. Fast-track designation allows for certain benefits, including opportunities for frequent interactions with the FDA, that may enable designated drugs to reach market sooner.
Prior to this designation, the FDA had granted ZMapp an orphan drug designation, which provides financial and other regulatory incentives meant to encourage development of drugs and other products targeting rare diseases.
The goal of both designations is to encourage scientists to research and develop treatments for diseases that may otherwise be overlooked.
Source: Mapp Biopharmaceutical; September 17, 2015.