The US Food and Drug Administration (FDA) has given Ebola experimental drug ZMapp "Fast Track" approval, as announced by LeafBio Inc. on Thursday, Sept 17. LeafBio is the commercial branch of Mapp Biopharmaceutical Inc. (Mapp), which manufactures the drug.
FDA awards the "Fast Track" designation to medicines that the agency thinks may possibly alleviate a severe health condition and an unmet medical concern. The basis of this designation may be rooted from either clinical or nonclinical information. Through this designation, frequent communications with the FDA may be allowed, which is something that could pave the way for designated medicines to be available in markets sooner.
Aside from that, this type of approval may hasten the process of accomplishing and receiving a positive remark of a Biologics License Application, which pertains to the application that must be submitted and approved by the FDA before a drug can be marketed in the US. The Fast Track designation of ZMapp, however, does not have an impact on the current clinical studies being performed in the West Africa.
Before ZMapp was able to obtain its latest designation, it has been regarded as an "orphan drug," which is a special status given to drugs as per request of a sponsor, who will be awarded with several incentives such as tax credits, financial and regulatory benefits. Through this, further development of medicines intended to treat rare diseases will be encouraged.
Fast Track and Orphan Drug designations both aim to urge scientists to study and create treatment for health conditions that may be overlooked.
"We have been consulting frequently with the FDA during the development of ZMapp," said Dr. Larry Zeitlin, the president of LeafBio and Mapp in a press release. The company is thankful for the agency's intention to collaborate with them for interactive analysis. The Fast Track designation is indeed a milestone, he added.
Mapp Biopharmaceutical has been developing an Ebola treatment for more than 10 years.
ZMapp was first administered to Dr. Kent Brantly after contracting the virus that has caused 28,256 morbidities and 11,306 mortalities since March 2014. Brantly's ZMapp therapy was performed under an emergency authorization, together with nine other individuals from the Western Europe and West Africa, said the National Institutes of Health (NIH).
The supply of ZMapp is limited and the manner with which it is produced takes time complete. The drug is made by first instilling proteins to tobacco plants and the entire procedure may take up to six months. The Obama administration has already asked three laboratories to work on the medicines to amp up its production.
LeafBio and Mapp are grateful for the Fast Track designation given to ZMapp, said Dr. Kevin Whaley, the CEO of the two companies. We are looking at the possibility of hastening the availability of the drug through this designation, he closed.
Photo: Army Medicine | Flickr
