Achaogen Drug Gets Split Decision on Safety and Effectiveness for UTIs, Bloodstream Infections

The FDA Antimicrobial Drugs Advisory Committee voted 15-0 that Achaogen’s NDA for plazomicin   proved safety and effectiveness for complicated urinary tract infections in patients with limited or no treatment options. But it voted 11 to 4 that the sponsor did not provide substantial evidence for its safety and effectiveness in treatment of bloodstream infections.

The company conducted seven safety studies for the drug. Only one death occurred among the cUTI patients, a 63-year-old woman who was discontinued from the study drug due to acute kidney injury and was found to have metastatic uterine cancer at the time of discontinuation. The sponsors could not fully exclude a relationship with plazomicin, but said the patient in question had “other significant comorbidities.” Observed adverse events included diarrhea, which affected 1 percent of subjects, and headache, which affected 0.7 percent.

The sponsor found a statistically significant benefit from plazomicin over colistin for 28-day mortality in the bloodstream infection subgroup, but not in the overall study population. Meanwhile, the efficacy study results for cUTI support plazomicin’s noninferiority to meropenem for treatment.