FDA panel to vote on Pharmaxis’s NDA
An independent advisory panel will vote today on whether to recommend the US FDA approve Pharmaxis’s (ASX:PSX) NDA for Bronchitol as a cystic fibrosis treatment.
Pharmaxis (ASX:PXS) has entered a trading halt ahead of today’s pivotal review of Bronchitol by an advisory panel to the US FDA.
The independent Pulmonary-Allergy Drug Advisory Committee (PADACS) will meet tomorrow to discuss Pharmaxis’s New Drug Application (NDA) for Bronchitol as a cystic fibrosis treatment.
PADACS’ published meeting materials show that the panel will first discuss the evidence supporting the efficacy and safety profile of Bronchitol, first in patients six years and older and then specifically in children and teenagers.
The panel will then vote on whether the safety and efficacy data included in the NDA are sufficient to recommend approval by the FDA.
Pharmaxis expects to be able to announce the results of the PADACS meeting on Thursday morning and has requested and received a trading halt until normal trading resumes on that day.
Bronchitol is a proprietary formulation of mannitol, administered as a dry powder through an inhaler. It is designed to reduce the mucus build-up in the lungs of respiratory patients.
The product has been approved in Europe and has a PBS listing in Australia.
Pharmaxis also uses mannitol in Aridol, its lung-function test for asthma patients.
Pharmaxis (ASX:PXS) shares were trading at $1.25 when the halt took effect.
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