(Adds details from panel meeting)
Nov 4 (Reuters) - The benefit of Cempra Inc 's CEMP.O antibiotic to treat community-acquired pneumonia outweighs the risk of liver injury, an advisory panel to the U.S. Food and Drug Administration narrowly concluded on Friday.
The panel voted 7-6 that the effectiveness of the drug, solithromycin, in treating the kind of pneumonia that recently affected U.S. presidential candidate Hillary Clinton outweighs concerns it could cause serious liver problems.
The FDA is not obliged to follow the recommendations of its advisory panels but typically does so.
Panelists voted unanimously that the drug is as effective as the potent antibiotic moxifloxacin. All but one said the company had not fully characterized the potential risk of liver injury. And a narrow majority concluded additional data should be collected after approval rather than before.
"I feel we could wait if the bugs would just slow down," Ellen Andrews, executive director of the Connecticut Health Policy Project said.
Solithromycin is descended from a notorious drug made by Sanofi SA SASY.PA called Ketek, or telithromycin. Ketek was approved by the FDA in 2004 but later linked to dozens of serious or fatal liver problems and largely withdrawn.
Panelists broadly expressed concern about increases in liver enzymes seen in clinical trials with solithromycin, which can be a sign of underlying liver disease. The elevated enzymes were transitory and there was no evidence of acute liver damage.