FDA panel narrowly backs Cempra antibiotic

A panel of federal health advisers has narrowly recommended approval for an experimental antibiotic from Cempra Inc., a small North Carolina drugmaker.

The Food and Drug Administration's outside experts voted 7-6 in favor of the drug, saying its effectiveness outweighed risks of seen in company studies. The vote is nonbinding but the FDA often follows the advice of its panelists.

Cempra is one of a handful of drugmakers developing new antibiotics amid growing to decades-old drugs like penicillin.

On Wednesday Cempra shares plunged more than 60 percent after the FDA posted an online review highlighting irregular liver enzyme measurements reported with the drug, called solithromycin. Shares rose 3 percent before closing Friday.

Explore further

Cempra shares plummet ahead of FDA meeting on antibiotic

© 2016 The Associated Press. All rights reserved.

Citation: FDA panel narrowly backs Cempra antibiotic (2016, November 4) retrieved 10 April 2021 from https://medicalxpress.com/news/2016-11-fda-panel-narrowly-cempra-antibiotic.html
This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only.

Feedback to editors

User comments