THURSDAY, SEPTEMBER 29, 2016

Ebola drug ZMapp gains fast-track status from the FDA

ZMapp gains fast track status from the FDA | Courtesy of angelfire.com
LeafBio Inc.,  the commercial arm of Mapp Biopharmaceutical Inc., recently announced that its ZMapp has gained fast-track status designation from the U.S. Food and Drug Administration (FDA) as a potential treatment for Ebola.

“We are gratified to receive this designation for ZMapp,” LeafBio and Mapp CEO Kevin Whaley said. “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.”

The FDA only grants fast-track designation to specific drugs that show potential in addressing previously unmet medical needs and are designed to treat only serious conditions. The FDA uses nonclinical as well as clinical data to determine whether a treatment qualifies for fast-track designation.

Fast-track status gives companies and drugs certain benefits, including interactions with officials at the FDA. This may allow the drugs to gain access to the market sooner.

“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,” LeafBio and Mapp President Larry Zeitlin said. “The formalization of this through fast-track designation is an important milestone.”

Organizations in this story

Mapp Biopharmaceutical 6160 Lusk Boulevard San Diego, CA 92121

U.S. Food and Drug Administration (FDA) 10903 New Hampshire Ave Silver Spring, MD 20903

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