Ebola vaccine ZMapp hits a milestone
Yesterday, makers of the experimental Ebola drug – ZMapp announced that the U.S. Food and Drug Administration (FDA) has granted a ‘Fast Track’ designation of the drug for the treatment of Ebola virus disease.
Dr. Larry Zeitlin, president of LeafBio and Mapp Biopharmaceutical said the company had been in frequent consultation with the FDA during the development of the drug, adding that the decision made by the FDA is an important milestone that could bring them closer to gaining approval. The Fast Track designation ultimately quickens ZMapp’s arrival in the market.
ZMapp was first tested on Dr. Kent Brantly, an American missionary worker who became sick with Ebola in Liberia. Nancy Writebol, a fellow missionary that was also infected, was the second person to receive the experimental drug. Following that, as of Februaury, the drug was already administered to nine infected patients in Africa (Liberia), the United States, and Western Europe under emergency use authorization.
Not all those who were given the drug survived, but some survivors of Ebola, believe ZMapp was their cure. Doctors have said it is unclear whether the drug was accountable for patient’s survival because it was not given within the context of a clinical trial. However, the drug which is currently undergoing a clinical trial in West Africa, was used to treat infected healthcare workers during the recent outbreak of Ebola in the region.
The experimental drug is derived from tobacco leaves, and has been in development for over a decade. The company had come out to say supply of the drug was limited because it sent all available doses to west Africa free of charge after an outcry over its use on foreign aid workers. Following that announcement, the Obama administration asked the labs working on the drug to scale up production.
Prior to the latest fast track designation, ZMapp was granted orphan drug designation by the FDA. This provides financial and other regulatory incentives meant to encourage development of drugs and other products targeted at rare diseases. “We are gratified to receive this designation for ZMapp … 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,” said Dr. Kevin Whaley, CEO of LeafBio and Mapp Biopharmaceutical.