A New Antibiotic is Nearing Approval, but Major Concerns Linger

A New Antibiotic is Nearing Approval, but Major Concerns Linger

A panel of U.S. Food and Drug Administration (FDA) experts has recommended that an experimental antibiotic made by Cempra Inc. be approved, but just barely. [1]

The panel voted 7-6 in favor of the drug, saying the effectiveness of the new antibiotic outweighed risks of liver toxicity seen in many studies. The FDA does not have to follow the panel’s recommendation, but it typically does.

A handful of drug companies are developing new medications in a race against the looming threat of antibiotic resistance. 

Source: The Chronicle

Cempra’s drug, solithromycin has been proven effective in treating community-acquired pneumonia, which develops in people with minimal or limited contact with medical institutions or settings. It is the same type of pneumonia that sickened Hillary Clinton on the campaign trail earlier this fall. Panelists voted unanimously that solithromycin works as well as moxifloxacin, but agreed that Cempra had not fully characterized the potential risk of liver damage. [2]

Clinical trials showed many more participants developed elevated liver enzymes while taking solithromycin than those taking moxifloxacin. Elevated liver enzymes can be a sign of underlying liver damage.

The panelists recommended that Cempra conduct further studies in order to determine the extent of the risk of liver toxicity after the antibiotic is approved.

At least 1 panel member said votes may have been swayed in favor of solithromycin because of the urgent need for new antibiotics to fight superbugs. Public health experts and scientists have warned that antibiotic-resistant superbugs could claim 10 million lives by the year 2050.

Ellen Andrews, executive director of the Connecticut Health Policy Project, said:

“I feel we could wait if the bugs would just slow down.”

Solithromycin is descended from the Sanofi-made drug Ketek, or telithromycin, which was discontinued after dozens of cases of serious or fatal liver problems were reported. The episode triggered allegations that the FDA downplayed concerns over the drug, which were articulated by its own reviewers.

On November 4, agency reviewers stated that “there is a very clear signature of hepatic injury” in the solithromycin clinical trial data.

If the FDA opts to approve solithromycin, the agency will likely place severe restrictions on its use, potentially making the antibiotic commercially unavailable. [3]

The agency is expected to decide on whether to approve solithromycin by December 27, but due to a manufacturing issue on Cempra’s end, that decision could be delayed.


[1] Associated Press

[2] Reuters

[3] The Street

The Chronicle

(Featured image not actual picture of solithromycin.)