The drug, solithromycin, was designed to treat pneumonia occurring in people with limited or no contact with healthcare settings. The antibiotic is a descendent of the controversial drug Ketek manufactured by Sanofi. Ketek was approved by the FDA in 2004 and was later linked to fatal liver problems and subsequently discontinued.
The FDA’s rejection letter noted the 920-patient dataset from clinical trials on the new drug weren’t substantial enough to completely understand the potential risk of liver injury. A preliminary FDA review of the drug detected a potential rise in liver enzymes associated with the medication’s use.
On Thursday, Cempra’s stock fell 48.3 percent to $3.15 in premarket trading, according to Reuters.
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