Colobreathe colistimethate sodium regulatory update

The U.K.'s NICE issued a final appraisal determination (FAD) recommending Colobreathe colistimethate sodium from Forest to treat chronic pulmonary infection caused by Pseudomonas aeruginosa in cystic fibrosis (CF) patients if nebulized colistimethate, a generic antibiotic, is not tolerated. The decision is contingent on Forest providing Colobreathe at an undisclosed discount under a patient access scheme. The FAD reverses a draft guidance issued last October (see BioCentury, Oct. 29, 2012). Final guidance is expected in March. ...