An independent advisory panel to the US Food and Drug Administration (FDA), has voted 7-6 that the regulatory agency should approve Cempra’s antibiotic drug, solithromycin. The close vote found that solithromycin’s ability to combat community-acquired bacterial pneumonia (CABP) outweighed its potential risks.
While the drug showed efficacy across multiple clinical trials, the committee was concerned about the drug’s potentially negative effects on the liver. The FDA advisory committee concluded that Cempra had failed to provide sufficient safety data on solithromycin, in order to fully assess its risks.
“We appreciate the meaningful discussion from today’s panel,” said Dr. Prabhavathi Fernandes, president and CEO of Cempra. “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.”
Despite the committee’s decision, analysts are not convinced that the FDA will follow their recommendation to approve solithromycin. Though the FDA often does follow the guidance of the independent advisory panel, it is not obligated to do so.
“Antibiotic resistance is reaching alarming rates across the globe,” said Fernandes. “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.”
If solithromycin gains regulatory approval, it will be the first new macrolide antibiotic with both an oral and an IV formulation in more than 20 years. Cempra is also awaiting an approval decision by the European Medicines Agency (EMA).