Dec 29 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
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
(Reporting by Natalie Grover and Akankshita Mukhopadhyay in
Bengaluru; Editing by Shounak Dasgupta)