Ar­a­digm com­pletes dis­as­trous reg­u­la­to­ry run as FDA slaps down Lin­haliq ap­pli­ca­tion

Ar­a­digm has com­plet­ed the reg­u­la­to­ry tri­fec­ta for dis­as­ter, stum­bling from a bad FDA re­view to a neg­a­tive pan­el vote and now a for­mal re­jec­tion for its in­haled an­tibi­ot­ic Lin­haliq that will re­quire a whole new Phase III pro­gram to over­come.

The writ­ing for this as­set has been on the wall since an out­side pan­el of agency ex­perts shook their heads over the mixed da­ta gath­ered in two late-stage tri­als for the an­tibi­ot­ic, an in­haled for­mu­la­tion of ciprofloxacin which is de­signed to fight lung in­fec­tions trig­gered by “ab­nor­mal di­lata­tion of the bronchi and bron­chi­oles.” Reg­u­la­tors had al­ready dissed the da­ta in their in­ter­nal re­view.

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