In-house FDA review flags a suspicious imbalance in deaths as Shionogi hunts an OK for antibiotic
Shionogi has some big questions to answer if they plan to win an FDA panel’s backing for their new antibiotic.
While investigators have provided positive efficacy data for their new product to treat cases of complex urinary tract infections, an FDA review has flagged an imbalance of deaths between the antibiotic and a control arm — with a “higher mortality in cefiderocol-treated patients was observed in a trial in critically ill patients with a variety of infections due to carbapenem-resistant organisms.”
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