Tetraphase plots Q4 launch for first an­tibi­ot­ic af­ter long-await­ed OK for er­ava­cy­cline

It took a few years more than ex­pect­ed, but Tetraphase fi­nal­ly has a prod­uct to sell.

Late Mon­day, the biotech an­nounced that the FDA has ap­proved their lead an­tibi­ot­ic, er­ava­cy­cline, for com­pli­cat­ed in­tra-ab­dom­i­nal in­fec­tions (cIAI). The com­pa­ny ex­pects to launch the in­tra­venous drug as Xer­a­va in the US by the end of the year.

The news comes four years af­ter Tetraphase first post­ed pos­i­tive Phase III da­ta for the drug in this in­di­ca­tion, back when the com­pa­ny thought the an­tibi­ot­ic could al­so treat com­pli­cat­ed uri­nary tract in­fec­tions (cU­TI). As er­ava­cy­cline flopped the late-stage study for cU­TI, reg­u­la­tors sent the com­pa­ny’s first NDA back de­mand­ing a sec­ond set of re­sults.

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