Kuwait Times

FDA panel narrowly backs Cempra antibiotic

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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

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