The FDA’s Pulmonary‐Allergy Drugs Advisory Committee (PADAC) has voted to recommend approval of Chiesi’s NDA for Bronchitol DPI for the treatment of cystic fibrosis in adult patients. According to Bronchitol developer Pharmaxis, Chiesi re-submitted the NDA in December 2018.
Bronchitol is already approved in Australia, Russia, and in Europe, where it was okayed in 2012, but the FDA issued a complete response letter to the original NDA for Bronchitol in 2013.
PADAC’s vote on the question, “Is the benefit‐risk profile adequate to support approval of DPM (dry powder mannitol) for the proposed indication of the management of cystic fibrosis to improve pulmonary function in patients 18 years of age and older in conjunction with standard therapies?” was 9 members yes, 7 no.
Pharmaxis CEO Gary Phillips commented, “The committee vote is very encouraging, however, we are aware that these recommendations are not binding and Pharmaxis will continue to support Chiesi to work with the FDA to bring Bronchitol to patients in the US. We expect the FDA to make its final decision by mid‐year.”
Pharmaxis will be due a $10 milestone payment from Chiesi on commercial launch if the FDA approves Bronchitol. The DPI will be manufactured by Pharmaxis and marketed by Chiesi in the US.
Read the Pharmaxis press release.
