FDA Panel backs Cempra’s Pneumonia Drug

11/6/16

Cempra Inc., a clinical-stage pharmaceutical company, has created an antibiotic to treat pneumonia that outweighs the risk of liver injury, an advisory panel to the U.S. Food and Drug Administration concluded in a 7-6 vote on Friday.

A positive recommendation typically leads to FDA approval. Panelists voted unanimously that the drug, solithromycin, works as well to treat pneumonia, but most said the company had not fully characterized the potential risk of liver injury.

On Friday agency reviewers stated that “there is a very clear signature of hepatic injury” in the solithromycin clinical trial data. Hepatic means “of the liver.”

The drug would treat the kind of pneumonia that recently affected U.S. presidential candidate Hillary Clinton.

Clinical trials showed a greater number of patients taking solithromycin developed elevated liver enzymes than those taking another drug, moxifloxacin. Elevated liver enzymes can be a sign of underlying liver damage.

Panelists recommended the company be required to conduct additional studies to further assess the potential liver risk after the drug has been approved.

Cempra’s drug is similar to Ketek, another antibiotic that was approved by the FDA in 2004 but later linked to dozens of serious or fatal liver problems and eventually discontinued in 2007.

Cempra’s shares did not trade Friday. NASDAQ halted trading until the FDA decision was announced.

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