Novartis’ Tobramycin Inhalation Powder May Face Questions Over Study Endpoint
This article was originally published in The Pink Sheet Daily
Executive Summary
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.
You may also be interested in...
Novartis’ TOBI Podhaler: Can Patient Satisfaction Overcome FDA’s Clinical Concerns?
FDA seems to find the data from the pivotal trials of the inhalation powder drug-device combination for the management of cystic fibrosis patients with Pseudomonas aeruginosa something less than persuasive.
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.
Ranbaxy’s Atorvastatin Recall: Will Glass Shards Nick FDA’s Reputation?
Less than a year after signing a consent decree to resolve compliance problems, the company is forced to stop manufacturing its generic version of the best-selling cholesterol drug. For FDA, the issue poses a public relations challenge since it touches on several areas where the agency has recently been criticized – generic drug quality, manufacturing oversight and drug shortages.