Modeling breakpoints

An FDApanel's advice on how to gauge antibiotic resistance could result in a more level playing field for new and old antibiotics. But at least three antibiotics developers contacted by BioCentury are uncertain how the changes will affect uptake of newer drugs.

On Oct. 17, FDA's Anti-Infective Drugs Advisory committee recommended the use of new pharmacokinetic and pharmacodynamic modeling that incorporates microbiologic data and some clinical data to set new susceptibility and resistance breakpoints for older antibiotics to treat serious infections, including acute bacterial skin and skin structure infections (ABSSSI), complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI)...