ZMapp has been granted fast track approval by the FDA
The experimental drug was given to the first American treated in the U.S. for Ebola
ZMapp, an experimental drug that was given to the first American treated in the United States for Ebola, has been granted fast track approval by the FDA, according to LeafBio. LeafBio is the commercial arm of Mapp Biopharmaceutical, the makers of the drug.
A press release posted on the company website proclaimed this as an “important milestone” which brings them closer to eventually gaining FDA approval.
“We are gratified to receive this designation for ZMapp,” said Dr. Kevin Whaley, CEO of LeafBio and Mapp. “We are hopeful that this step will accelerate access to ZMapp once safety and efficacy are demonstrated to FDA’s satisfaction in ongoing clinical trials.”
This is a change from the previous status as an orphan drug, which provided incentive for development of the drug financially and otherwise.
Dr. Kent Brantly was the first human to receive the drug after becoming ill with the virus that has infected 28,256 people and killed 11,306 since March 2014.
He was working as a missionary in Liberia. His fellow missionary, Nancy Writebol, was also infected and was the second person to receive the experimental drug. Brantly was transported to Emory University hospital, where he was treated and declared Ebola-free, as was Writebol.
According to the National Institutes of Health, the drug was administered under emergency use authorization to nine infected patients in Africa, the United States and Western Europe as of February, when the NIH announced the first clinical trial of ZMapp in Liberia and the United States.
Doctors have said it is unclear whether the drug was accountable for patients’ survival because it was not given within the context of a clinical trial. In addition, patients were cared for in other ways simultaneously.
The drug, produced using proteins that are first injected into tobacco plants, takes six months to produce and supply has been extremely limited. In October the Obama administration asked the three labs working on the drug to scale up production.
According to Mapp Biopharmaceutical documents, four monkeys infected with Ebola survived after being given the therapy within 24 hours after infection. Two of four other monkeys that started therapy within 48 hours after infection also survived. One monkey that was not treated died within five days of exposure to the virus.
The medicine is a three-mouse monoclonal antibody, meaning that mice were exposed to fragments of the Ebola virus and then the antibodies generated within the mice’s blood were harvested to create the medicine. It works by preventing the virus from entering and infecting new cells.
Scientists racing to develop something that will stop the Ebola epidemic are trying a variety of experimental drugs, including Brincidofovir, an experimental antiviral drug that was initially being developed to treat life-threatening viruses like smallpox; TKM-Ebola, which is made by Canadian company Tekmira Pharmaceuticals; and a vaccine developed by GlaxoSmithKline and the National Institute of Allergy and Infectious Diseases.