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 drug maker. The Food and Drug Administration’s outside experts voted 7-6 in favor 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 drug makers developing new antibiotics amid growing bacterial resistance to decadesold 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. — AP