MIAMI, Florida -- The experimental Ebola drug ZMapp has been
granted fast-track status by the U.S. Food and Drug Administration, which could
speed its arrival on the market, the drugmaker said Thursday.
Larry Zeitlin, president of
LeafBio and Mapp Biopharmaceutical, described the decision by the FDA as an
"important milestone."
ZMapp
was used to treat some of the healthcare workers infected with Ebola during the
recent outbreak in West Africa, even though the drug had never undergone a
full-scale clinical trial.
Not all
those who were given the drug survived, but some who were cured of Ebola
believe it worked for them.
A
clinical trial of ZMapp is taking place in West Africa.
The
drug has been in development for more than a decade, but it is derived from
tobacco leaves and the company has said "very little" of the drug is
available.
Prior
to getting fast-track status, ZMapp had been granted "orphan drug"
designation, which provides financial and other regulatory incentives meant to
encourage development.
"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 Kevin Whaley,
chief executive officer of LeafBio and Mapp Biopharmaceutical, based in San
Diego, California.
Other
partners in the drug's development include Defyrus Inc. of Toronto, Canada, the
U.S. government and the Public Health Agency of Canada.
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