For the latest media releases and news about Pharmaxis Ltd, please select from the following articles. Material news announcements made by Pharmaxis are first filed with the Australian Securities Exchange (ASX) and are also available on the ASX website.
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
Pharmaceutical research company Pharmaxis Ltd (ASX: PXS) today announced the US Food and Drug Administration (FDA) will convene a Pulmonary-Allergy Drugs Advisory Committee (PADAC) on 8 May 2019 (US time) to make recommendations on the use of Bronchitol® for adult cystic fibrosis patients in the United States.
The Bronchitol New Drug Application was resubmitted to the FDA in December 2018 by Pharmaxis licensee, Chiesi Group (Chiesi) who are responsible for the regulatory approval process. Pharmaxis is supporting Chiesi in its preparations for the PADAC meeting.Read full media release - pdf
Boehringer Ingelheim Completes Enrollment of Phase 2a Clinical Trial of Pharmaxis Developed Drug in NASH
Pharmaceutical research company Pharmaxis Ltd (ASX: PXS) today announced completion of enrollment in Boehringer Ingelheim’s Phase 2a clinical trial in patients with non-alcoholic steatohepatitis (NASH). The trial is assessing BI 1467335 (formerly known as PXS-4728A), an oral inhibitor of amine oxidase, copper containing 3 (AOC3), that works by blocking leucocyte adhesion and tissue infiltration in inflammatory processes underlying NASH. BI 1467335 was acquired from Pharmaxis in May 2015 and is also in an ongoing Boehringer Ingelheim Phase 2a clinical trial for diabetic retinopathy.
The Phase 2a NASH trial is a multi-centre, double-blind design in 114 patients with clinical evidence of NASH. The trial is being conducted in nine countries across North America and Europe. The primary objectives are to establish proof of clinical principle, investigate suitable dosing, and to evaluate the safety of BI 1467335. Patients have been randomized to either one of four dosages of BI 1467335 or to placebo for a 12-week treatment period followed by a 4-week observation period. The trial is expected to report in the second half of 2019. A subsequent Phase 2b study will seek to confirm and extend these findings.Read full media release - pdf