FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Advisory Panel Votes in Support of Cystic Fibrosis Drug

May 16, 2019
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An FDA advisory committee voted in favor of Chiesi’s Bronchitol (inhaled mannitol) for improving lung function in cystic fibrosis patients aged 18 and older.

The Pulmonary-Allergy Drugs Advisory Committee voted 10-6 in favor of the drug’s efficacy and safety but almost split evenly on the question of the drug’s benefit-risk, voting just 9-7 in favor.

“Based on the data presented, Bronchitol appears to be safe and effective as an alternative therapy, particularly for patients who can’t tolerate hypertonic saline,” said Michael Boyle, founder of the Johns Hopkins Adult CF foundation, who noted the drug has been approved in 35 countries so far.

The “yes” votes prevailed despite concerns noted by the FDA over serious exacerbations in some patients.

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