FDA approves Bronchitol inhalation powder

2 November 2020

The US Food and Drug Administration has approved the new drug application for Bronchitol (mannitol) inhalation powder submitted by the US subsidiary of Italian privately-held drugmaker Chiesi Farmaceutici.

Bronchitol is the first and only inhaled dry powder indicated as add-on maintenance therapy to improve pulmonary function in cystic fibrosis (CF) patients 18 years of age and older. It provides a compact, portable option to CF patients. Bronchitol was developed by Australia’s Pharmaxis (ASX: PXS), and Chiesi is now its exclusive distributor in the USA and 11 other countries.

Pharmaxis’ shares shot up as much as 62%, and closed the day 25% higher at A$0.11 on the news. The approval triggers a $7 million payment for the firm from Chiesi. This will be followed by another $3 million upon shipment of stock.

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