Pharmaxis Ltd. has resubmitted an application for its cystic fibrosis medicine Bronchitol to the U.S. Food and Drug Administration after adding in new clinical trial data from a phase 3 study.
The Australian company said in a Dec. 20 press release that the new drug application for Bronchitol has been resubmitted for the treatment of cystic fibrosis. The inhaler helps rehydrate the lungs to promote a productive cough.
The FDA rejected Pharmaxis' new drug application for Bronchitol in March 2013 and requested a new clinical trial be conducted to provide for further evidence of the therapy's benefit-risk balance. The agency determined that the phase 2 studies that had been conducted noted that a number of patients dropped out of the trial, and some pediatric patients coughed up blood while receiving the treatment.
The new submission includes results from a phase 3 clinical trial that was conducted to assess Bronchitol after consultation with the FDA. Results of the trial were issued in June 2017.
Pharmaxis said the FDA's review should take between six and 12 months to complete.
Bronchitol was developed by Pharmaxis, but has been licensed by Chiesi Farmaceutici SpA The Italian company is responsible for regulatory approval and commercialization of the drug in the U.S. If the FDA approves the medicine, Pharmaxis will be eligible for a $10 million milestone payment once it launches plus royalties, and will be the exclusive U.S. distributor of the drug.
Pharmaxis develops human healthcare products for the treatment and management of chronic diseases worldwide.