FDA rejects Cempra’s antibiotic for pneumonia, shares sink

Cempra Inc said on Thursday the U.S. Food and Drug Administration had rejected its antibiotic for community-acquired bacterial pneumonia (CABP), citing inadequate data on the drug’s impact on the liver and manufacturing issues. The FDA did not ask for further data on solithromycin’s effectiveness in treating CABP, Cempra said. An independent FDA panel narrowly backed the drug, solithromycin, in November, although a preliminary staff review by FDA scientists highlighted a potentially concerning rise in liver enzymes associated with its use.
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