Bayer to Ask FDA Panel to Support Use of Cipro for Anthrax

by Brian Reid

Bloomberg Business News

June 9, 2000

Washington, June 9 (Bloomberg) -- Bayer AG will ask a U.S. Food and Drug Administration panel next month to recommend approval of its blockbuster Cipro antibiotic for use in patients exposed to anthrax, the world's deadliest biological agent.

Research shows Cipro is even effective against strains of anthrax biologically engineered to resist other antibiotics. That could make Cipro an important alternative treatment in the wake of a bio-terrorism attack.

An FDA advisory panel on July 28 will consider whether Cipro, known chemically as ciprofloxacin, can protect patients who've been exposed to the bacteria and warrants FDA approval. The agency usually follows the advice of its expert panels.

One group of academics and government defense and public health experts has already recommended approval of Cipro for that use. ``Balancing considerations of efficacy with concerns regarding resistance, the working group recommends that ciprofloxacin . . . be initiated in adults'' who may have been exposed to anthrax, the Working Group on Civilian Biodefense wrote in the Journal of the American Medical Association last year.

The group also advised that children exposed to anthrax be given Cipro as an initial therapy.

Though other antibiotics, including penicillin and doxycycline, can be used to treat patients exposed to anthrax, the working group said strains of anthrax have been biologically engineered to resist those drugs may make Cipro the best choice for initial treatment.

Bayer, Germany's largest drugmaker, asked the FDA to approve the new use of Cipro after discussions with the agency, company spokeswoman Mary Sawyers said.

The drug has only been tested against anthrax in animal model; testing it in humans would be unethical, Sawyers said.