ZMAPP, an experimental drug administered to the first American treated for Ebola in the United States, has been given fast track status by the Food and Drug Administration (FDA) for further development. ZMAPP was first given to Dr. Kent Brantly, the medical missionary air-evacuated from Liberia at the height of the Ebola outbreak in 2014. The drug is currently being tested in Liberia, according to NBC.
After LeafBio Inc., the company’s commercial arm, made the announcement, Mapp Biopharmaceutical posted a press release celebrating the fast track’s importance for their ultimate goal of FDA approval.
“We have been consulting frequently with the FDA during the development of ZMapp and are grateful for their willingness to work with us to provide interactive review,” Dr. Larry Zeitlin, president of LeafBio and Mapp, said in a press release on the company website. “The formalization of this through Fast Track designation is an important milestone.”
The ZMAPP drug was previously classified as an orphan drug, which means that it was developed specifically to treat a rare medical condition. The drug is made using three lab-engineered immune system proteins called monoclonal antibodies which specifically target the Ebola strain. However, supply of ZMapp has also been limited since it takes six months to produce using proteins injected into tobacco plants.
Doctors have said it is uncertain whether the drug was accountable for patients’ survival since it has yet to be given in the framework of a clinical trial, although LeafBio and Mapp CEO Dr. Kevin Whaley assured the public in the company’s press release that this would soon change as a result of the fast track.
“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,” Whaley said.
Information for this article was taken from CNN.com, NBC.com, mappbio.com.