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FDA Panel Recommends Approval of Antibiotic

February 20, 1998| From Times Wire Services

GAITHERSBURG, Md. — Advisors to the Food and Drug Administration voted Thursday to recommend limited approval of the first new antibiotic designed to battle drug-resistant bacteria.

The recommendation comes just months after doctors discovered that strains of the common Staphylococcus germ are developing resistance to today's antibiotic of last resort, vancomycin.

Synercid, developed by Rhone-Poulenc Rorer Inc., is the first of a new class of antibiotics called streptogramins. The FDA isn't bound by the panel's support for approval, but it generally follows it. The agency has promised a final decision by next month.

The panel voted overwhelmingly that Synercid can treat serious skin infections and the more dangerous hospital-acquired pneumonia--diseases typically caused by a germ called Staphylococcus aureus, which often requires vancomycin treatment when nothing else works.

Studies showed Synercid successfully fought these infections in 50% to 66% of patients, equal to standard therapy.

Rhone-Poulenc Rorer, the pharmaceutical unit of France's Rhone Poulenc, asked for approval to treat many infections, including pneumonia and bloodstream and skin infections, caused by bacteria that have become resistant to the drugs used to treat them.

The panel also recommended approval for use against hospital-acquired pneumonia but rejected approval for use against community-acquired pneumonia.

The advisors were concerned not only that Synercid might not work well against community-acquired pneumonia but also were worried that bacteria might develop resistance to the drug if it is used too widely.

In clinical trials, Synercid seemed to work best against infections acquired in the hospital and against E. faecium and S. aureus strains. Joint and muscle pain was the most common side effect.

Rhone predicts it will sell well to hospitals.

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