FDA grants ‘break­through’ sta­tus to an­tibi­ot­ic al­ter­na­tive as Con­tra­Fect rush­es to join fight against su­per­bug

An ex­per­i­men­tal drug that promis­es to be the first an­ti-in­fec­tive agent to prove su­pe­ri­or to van­comycin — an an­tibi­ot­ic ap­proved in 1958 — has notched the FDA’s “break­through” sta­tus.

Con­tra­Fect said the des­ig­na­tion was based on Phase II da­ta in which exe­ba­case was test­ed against a su­per­bug known as me­thi­cillin-re­sis­tant Staph au­reus, or MR­SA. In a sub­group analy­sis, the clin­i­cal re­spon­der rate at day 14 was 42.8% high­er than that among those treat­ed with stan­dard of care, the com­pa­ny said (p=0.010).

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