Posted by Michael Wonder on 06 May 2020
Chiesi files resubmission to address FDA Bronchitol (mannitol) inhalation powder complete response letter
5 May 2020 - Pharmaxis today announced its US licensee Chiesi has filed a resubmission that addresses the issues raised by the US FDA in a complete response letter received in June 2019 to the Bronchitol new drug application.
This resubmission follows Chiesi Group’s successful completion of a supplemental human factor study in Q1 2020 which was the most significant body of additional data required by the FDA.
The proposed indication for Bronchitol is management of cystic fibrosis to improve pulmonary function in patients 18 years of age and older in conjunction with standard therapies.
The FDA review of the Bronchitol application is expected to be completed in mid 2020.
