Cystic Fibrosis Trials: CDER Officials Disagree Over Value Of FEV1 Endpoint
There is an apparent split within FDA's Center for Drug Evaluation and Research on the usefulness of measuring the amount of air a patient can blow in one second as a primary outcome measure in trials of aerosolized antimicrobial drugs for cystic fibrosis.
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Novartis’ inhalation powder version of the antibiotic tobramycin appears to be much more convenient in treating Pseudomonas aeruginosa infections in cystic fibrosis patients than the currently marketed nebulized solution (Tobi), but the appropriateness of the FEV1 endpoint is likely to be a matter of dispute during advisory committee review.
Quality-of-life metrics deserve consideration in addition to lung function in the development of aerosolized antimicrobials, researchers say.
Gilead Sciences will price its cystic fibrosis drug Cayston at an 8 percent premium to its competitor, Novartis' TOBI (tobramycin)