Pharmaxis hopeful of FDA approval for cystic fibrosis inhalation medicine Bronchitol by Q1 2020
Pharmaxis Ltd (ASX:PXS) chief executive officer Gary Phillips updates Proactive Investors on the FDA approval timeframe for the company’s Bronchitol inhalation medicine used to treat adult cystic fibrosis patients.
The healthcare-focused company is confident it will meet information requirements for a Q1 2020 approval.
Earlier this year, the FDA Pulmonary and Allergy Drug Advisory Committee (PADAC) released a positive vote that provides a clear path to meet this approval, subject to some further information being provided, which is now being undertaken and delivered.
The CEO also updated the market on the company’s deal with Boehringer for liver disease medicine, as well as its LOXL2 inhibitor program.