FDA Panel Recommends NDAs for Bacterial Pneumonia, Skin Infections
An FDA advisory panel voted Wednesday in favor of the safety and efficacy of Paratek’s two NDAs for omadacycline tablets and omadacycline injection as treatments for community-acquired bacterial pneumonia (CAPB) and acute bacterial skin and skin structure infections (ABSSSI).
The Antimicrobial Drugs Advisory Committee voted 14 to 4 in favor of the drug’s safety and efficacy for CABP. Some members who voted “yes” expressed concerns about deaths among patient populations but noted that these could be attributed to the large numbers of comorbidities often found in CABP patients.
The committee voted 17 to 1 on the drug’s efficacy and safety for ABSSSI, citing the strength of the non-inferiority data. In the two Phase 3 ABSSSI trials, omadacycline showed non-inferiority to linezolid, according to the FDA. The agency noted similar non-inferiority for the Phase 3 CABP trials.
The two omadacycline NDAs carry an October PDUFA decision date.