Pivmecillinam (Pivya) was given the nod from the federal agency, and is indicated for female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus.
With this approval, aztreonam-avibactam becomes the first β-lactam/β-lactamase inhibitor antibiotic combination approved in the European Union for treating multidrug-resistant infections, including metallo-β-lactamase-producing bacteria.
In these patient encounters, a deep cough as a symptom raised concerns around pneumonia and may have prompted prescription of antimicrobials, but did not show a resolution of symptoms sooner.