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FDA: Cempra Antibiotic Approved in Panel Vote Despite Safety Concerns

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By    |   Monday, 07 Nov 2016 03:15 PM

An FDA panel has approved a new antibiotic from drug maker Cempra despite safety concerns about the drug.

Cempra's antibiotic solithromycin has been touted as a way to fight the last decade's growing number of drug-resistant viruses, but the panel's narrow 7-6 vote is far from inspiring confidence in a drug with a "significant safety signal," says STAT.

According to the medical news website, a regulatory review showed Cempra’s antibiotic draws similarities to Ketek, an older drug that caused fatal liver injuries.

“We predict eventual approval with no additional pre-marketing studies, but extensive post-marketing studies and label warnings,” said Cowen analyst Ritu Baral, STAT reported.

Edward Nash, an analyst at SunTrust Robinson Humphrey, wrote in an investor note that one of the panel members who voted against the approval "explicitly stated that he would have voted yes if Cempra had had a clear strategy in how to respond to post-marketing safety findings," STAT reported.

If the drug is approved, Cempra says it will be the first new macrolide antibiotic containing an oral and IV formation in more than two decades, according to Fierce Biotech.

Prabhavathi Fernandes, president and chief executive officer of Cempra, released a statement after the narrow FDA approval last week.

"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," she said.

Cempra shares plummeted more than 60 percent following an FDA online review that focused on "irregular liver enzyme" measurements in the drug, but recovered after the panel's approval.

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An FDA panel has approved a new antibiotic from drug maker Cempra despite safety concerns about the drug.
FDA, cempra, antibiotic
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2016-15-07
Monday, 07 Nov 2016 03:15 PM
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