The resubmission responds to matters raised by the FDA in its Complete Response Letter issued in March 2013 and includes the results of the phase 3 clinical trial conducted after consultation with the FDA.
Bronchitol is a precision spray‐dried form of mannitol, delivered to the lungs by a specially designed, portable inhaler.
It works by rehydrating the airway/lung surface and promoting a productive cough. Bronchitol is used for the treatment of cystic fibrosis patients.
Pharmaxis expects the FDA review process to take between six and 12 months to conclude. Chiesi is responsible for the regulatory approval and commercialisation of Bronchitol in the US.
If Bronchitol is approved by the FDA, Pharmaxis will receive a US$10 million milestone payment on the commercial launch of Bronchitol in the US and, mid to high teen percentage royalties on in‐market net sales.
Pharmaxis chief executive officer Gary Phillips said: “The resubmission of the Bronchitol NDA concludes a substantial investment and effort by Pharmaxis and Chiesi over an extended period of time.
“We will continue to support Chiesi in progressing the application with the FDA and look forward to the conclusion of the review in the second half of 2019.”