Cempra's Experimental Antibiotic Gets Tepid Recommendation From FDA Advisory Panel

Cempra Inc CEMP on Friday said that a majority of the US FDA’s Antimicrobial Drugs Advisory Committee [AMDAC] had voted in favor of the efficacy results of solithromycin outweighing the risks.

Cempra’s shares surged almost 20 percent in pre-market trade on Monday.

The company’s shares hovered around the $9 mark on news of solithromycin’s efficacy results for the treatment of community-acquired bacterial pneumonia [CABP] outweighing risks. The vote, however, was a close one, with a 7-6 tally. Cempra’s shares have lost close to 80 percent year-to-date.

AMDAC Voting

The AMDAC members unanimously voted for there being substantial evidence of solithromycin’s efficacy for CABP. The committee also voted 12:1 that the risk of hepatotoxicity with solithromycin “had not been adequately characterized” and discussed various potential approaches to further characterize the existing liver safety information on solithromycin, Cempra’s press release stated.

"We appreciate the meaningful discussion from today's panel. Their supportive view and thoughtful comments on approaches to ensuring appropriate use are consistent with Cempra's commitment to make solithromycin available to the right patients for a five to seven day course of an oral and/or IV macrolide as monotherapy for CABP," Cempra’s CEO Prabhavathi Fernandes commented.

"Antibiotic resistance is reaching alarming rates across the globe. In the U.S. alone, pneumonia is the leading cause of death due to infectious disease and rates of pneumococcal resistance to current macrolides for the treatment of CABP can exceed 50 percent. We believe solithromycin has the potential to offer patients and physicians an important new treatment option and we look forward to continuing to work with the FDA as it completes its review," Fernandes added.

The FDA is scheduled to take action under the Prescription Drug User Fee Act on December 27 for the oral filing and on December 28 for the IV filings.

While the FDA is not bound by the Advisory Committee's guidance, it does take the advice into consideration when reviewing investigational medicines. If approved, solithromycin would be the first new macrolide antibiotic with an oral and IV formulation in more than two decades.