Pathway to US Approval Clarified After FDA Issues Complete Response Letter on Use of Bronchitol for Adult CF Patients - NDA Expected to be Completed Q1 2020
Pharmaceutical company Pharmaxis (ASX: PXS) today announced its US licensee Chiesi Group (Chiesi) has received a complete response letter from the US Food and Drug Administration (FDA) detailing the remaining matters to be addressed before Bronchitol® can be approved for adult cystic fibrosis (CF) 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.Read full media release - pdf
Pharmaceutical company Pharmaxis (ASX: PXS) today announced its US licensee Chiesi has received a positive recommendation from a Committee advising the US Food and Drug Administration (FDA) on the use of Bronchitol® for adult cystic fibrosis patients in the United States.
The deliberations of the Pulmonary-Allergy Drugs Advisory Committee (PADAC) took place over eight hours in Washington concluding early this morning AEDT. After voting separately on the efficacy evidence and the safety profile, 9 members of the 16 person committee voted YES to 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?”
Pharmaxis CEO Gary Phillips said, “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.”Read full media release - pdf