Posted by Michael Wonder on 20 Jun 2019
Pathway to US approval clarified after FDA issues complete response letter on use of Bronchitol for adult CF patients
20 June 2019 - Pharmaxis today announced its US licensee Chiesi has received a complete response letter from the US FDA detailing the remaining matters to be addressed before Bronchitol can be approved for adult cystic fibrosis patients in the United States.
Based upon the clear and achievable path to approval communicated in the FDA complete response letter, Pharmaxis believes that the FDA review of the Bronchitol NDA will be completed in Q1 2020.
The main requirement included in the FDA complete response letter is that Chiesi revise the product packaging and user instructions; and then conduct a human factor study demonstrating that the revised user components enable healthcare professionals to properly administer the mannitol tolerance test.
