WASHINGTON – 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 favour of the drug, saying its effectiveness outweighed risks of liver toxicity 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 bacterial resistance to decades-old drugs like penicillin.
On Wednesday Cempra shares plunged more than 60 per cent after the FDA posted an online review highlighting irregular liver enzyme measurements reported with the drug, called solithromycin. Shares rose 3 per cent before closing Friday.