Tobramycin inhalation powder regulatory update

The U.K.'s NICE issued a final appraisal determination (FAD) recommending TOBI Podhaler from Novartis to treat chronic pulmonary infection caused by Pseudomonas aeruginosa in cystic fibrosis patients if nebulized tobramycin is considered an appropriate treatment. The decision is contingent on Novartis providing TOBI Podhaler at an undisclosed discount under a patient access scheme. The guidance is in line with draft guidance issued last October (see BioCentury, Oct. 29, 2012). Final guidance is expected in March. ...