FDA panel nar­rowly backs Cem­pra an­tibi­otic

Kuwait Times - - HEALTH & SCIENCE -

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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