Ad­comm unan­i­mous­ly rec­om­mends En­ta­sis' bac­te­r­i­al pneu­mo­nia can­di­date for re­sis­tant in­fec­tions

All 12 mem­bers of the FDA’s An­timi­cro­bial Drugs Ad­vi­so­ry Com­mit­tee unan­i­mous­ly vot­ed Mon­day af­ter­noon in fa­vor of an an­tibi­ot­ic can­di­date from En­ta­sis Ther­a­peu­tics, say­ing that it has a fa­vor­able ben­e­fit-risk pro­file for treat­ing pa­tients with two hos­pi­tal-re­lat­ed bac­te­r­i­al pneu­mo­nias.

En­ta­sis brought the an­tibi­ot­ic be­fore the FDA to try and get the can­di­date, known as sul­bac­tam-dur­lobac­tam, ap­proved to treat hos­pi­tal‐ac­quired bac­te­r­i­al pneu­mo­nia (HABP) and ven­ti­la­tor‐as­so­ci­at­ed bac­te­r­i­al pneu­mo­nia (VABP), caused by strains of Acine­to­bac­ter bau­man­nii‐cal­coaceti­cus com­plex.

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