Ebola drug ZMapp gets fast track status from FDA
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The experimental Ebola drug ZMapp has been fast-tracked by the US Food and Drug Administration.
According to Mapp Biopharmaceuticals Inc., the status was given to them on Thursday by the FDA. According to Medical Daily, the status is mostly given to drugs that cure rare or serious conditions with little treatment options.
According to the drug maker, the designation is considered by them to be "an important milestone."
"We have been consulting frequently with the FDA during the development of ZMappTM and are grateful for their willingness to work with us to provide interactive review. The formalization of this through Fast Track designation is an important milestone," Dr. Larry Zeitlin, president of LeafBio and Mapp, said in a press release.
Furthermore, the status will enable the anti-Ebola drug ZMapp to be commercially available sooner than later.
"We are gratified to receive this designation for ZMappTM. We are hopeful that this step will accelerate access to ZMappTM once safety and efficacy are demonstrated to FDA's satisfaction in ongoing clinical trials," added CEO Dr. Kevin Whaley.
ZMapp has been in development for more than 10 years and according to Yahoo, the clinical trials are taking place in West Africa. It was previously used to treat infected healthcare workers during last year's Ebola outbreak in the area before a clinical trial could be conducted. Some of the surviving Ebola patients who were given ZMapp found it to be effective.
In a report by CNN, the first human to be given ZMapp was Dr. Kent Brantly after he was diagnosed with Ebola. The second person to be given the anti-Ebola drug was Nancy Writebol. According to the outlet, both were working as missionaries in Liberia when they got infected. Both of them were flown to Emory University hospital and were subsequently treated and declared free from the virus. It was unclear if the drug increased the patients' survival.
ZMapp is created from the antibodies generated from the mice's blood after it was exposed to Ebola virus. According to NBC News, the medicine works to protect the body's cells from Ebola. ZMapp is neither a cure nor a vaccine but a combination of two serums by two companies, according to Mashable. The first serum was developed by Mapp Biopharmaceuticals and the second was made by Canadian company Defyrus Inc.
According to the Centers for Disease Control and Prevention, there have been 11,308 total number of deaths from Ebola since the outbreak began last year.
