Dec 29 (Reuters) - Cempra Inc said the U.S. Food and Drug Administration rejected its antibiotic for community-acquired bacterial pneumonia (CABP), citing inadequate data on the drug’s impact on the liver, and unresolved manufacturing issues.
An independent panel to the U.S. FDA in November narrowly voted in favor of the drug, solithromycin, although in a staff review, FDA scientists highlighted a potentially concerning rise in liver enzymes associated with its use.
On Thursday, the FDA did not request any further information on solithromycin’s effectiveness in treating CABP, Cempra said.
Solithromycin, which is designed to be administered intravenously and via capsules, is descended from a notorious drug made by Sanofi SA called Ketek.
Ketek was approved by the FDA in 2004, but was later linked to dozens of serious or fatal liver problems, and was eventually discontinued. (Reporting by Natalie Grover and Akankshita Mukhopadhyay in Bengaluru; Editing by Shounak Dasgupta)