Chiesi Files Resubmission to Address FDA Bronchitol (Mannitol) Inhalation Powder Complete Response Letter
Release Date: 05/05/2020 8:30am
Pharmaceutical research company Pharmaxis Ltd (ASX: PXS) today announced its US licensee Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group) has filed a resubmission that addresses the issues raised by the US Food and Drug Administration (FDA) in a complete response letter received in June 2019 to the Bronchitol® New Drug Application (NDA). 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 NDA is expected to be completed in mid-2020.
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