Experiments with monkeys strongly support the antibacterial medication Levaquin as a useful means of countering pneumonic plague,
a U.S. Food and Drug Administration panel ruled on Wednesday in a
determination that could pave the way for the drug's designation as a
tool for containing a potential biological attack involving the lethal
bacteria .
The advisory group's nonbinding endorsement precedes an FDA decision anticipated on the issue closer to the end of April, the Newark Star-Ledger quoted Janssen Pharmaceuticals spokesman William Foster as saying. Janssen Pharmaceuticals is a branch of Johnson & Johnson, which produces the medicine.
The FDA advisers reached a comparable determination for Ciprofloxacin, an antibiotic manufactured by Bayer.
U.S. medical officials have sought endorsement for expedited applications of Levaquin, which national medical countermeasures stocks now incorporate as a hedge against deliberate or unintended spread of the disease.
The Johnson & Johnson medication has been established as useful against pneumonic plague, but FDA recognition of that fact is key to enabling its distribution in a crisis without an Emergency Use Authorization, according to National Institute of Allergy and Infectious Diseases head Anthony Fauci.
It would be "logistically complicated" to amass reserves of the medicine on the basis of such an authorization, he said.
“We wanted to get around the situation of having to evoke an emergency authorization," the official said, “but using the animal rule is a little different than developing a new drug."
The advisory group's decision marks a new use of an FDA regulation permitting evaluations of a drug's efficacy to be based solely in nonhuman trials in cases precluding evaluations on people.
http://www.nti.org/gsn/
The advisory group's nonbinding endorsement precedes an FDA decision anticipated on the issue closer to the end of April, the Newark Star-Ledger quoted Janssen Pharmaceuticals spokesman William Foster as saying. Janssen Pharmaceuticals is a branch of Johnson & Johnson, which produces the medicine.
The FDA advisers reached a comparable determination for Ciprofloxacin, an antibiotic manufactured by Bayer.
U.S. medical officials have sought endorsement for expedited applications of Levaquin, which national medical countermeasures stocks now incorporate as a hedge against deliberate or unintended spread of the disease.
The Johnson & Johnson medication has been established as useful against pneumonic plague, but FDA recognition of that fact is key to enabling its distribution in a crisis without an Emergency Use Authorization, according to National Institute of Allergy and Infectious Diseases head Anthony Fauci.
It would be "logistically complicated" to amass reserves of the medicine on the basis of such an authorization, he said.
“We wanted to get around the situation of having to evoke an emergency authorization," the official said, “but using the animal rule is a little different than developing a new drug."
The advisory group's decision marks a new use of an FDA regulation permitting evaluations of a drug's efficacy to be based solely in nonhuman trials in cases precluding evaluations on people.
http://www.nti.org/gsn/
