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Pharmaxis resubmits new drug application for Bronchitol in the US

Bronchitol works by rehydrating the airway/lung surface and promoting a productive cough. It is used for the treatment of cystic fibrosis patients.

A woman coughing
FDA review is expected to be completed in the second half of 2019

Pharmaxis Ltd’s (ASX:PXS) licensee Chiesi Group has resubmitted a new drug application (NDA) for Bronchitol with the US Food and Drug Administration (FDA).

The resubmission responds to matters raised by the FDA in its Complete Response Letter issued in March 2013 and includes the results of the phase 3 clinical trial conducted after consultation with the FDA.

READ: Pharmaxis meets primary endpoint of phase 3 trial of Bronchitol

Bronchitol is a precision spray‐dried form of mannitol, delivered to the lungs by a specially designed, portable inhaler.

It works by rehydrating the airway/lung surface and promoting a productive cough. Bronchitol is used for the treatment of cystic fibrosis patients.

Pharmaxis expects the FDA review process to take between six and 12 months to conclude. Chiesi is responsible for the regulatory approval and commercialisation of Bronchitol in the US.

READ: Pharmaxis reveals first sales of Aridol® in US following successful relaunch

If Bronchitol is approved by the FDA, Pharmaxis will receive a US$10 million milestone payment on the commercial launch of Bronchitol in the US and, mid to high teen percentage royalties on in‐market net sales.

Pharmaxis chief executive officer Gary Phillips said: “The resubmission of the Bronchitol NDA concludes a substantial investment and effort by Pharmaxis and Chiesi over an extended period of time.

“We will continue to support Chiesi in progressing the application with the FDA and look forward to the conclusion of the review in the second half of 2019.”

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Pharmaxis Ltd expects review of Bronchitol NDA to be completed by mid-2020

Pharmaxis Ltd (ASX:PXS) (OTCMKTS:PXSLY) (FRA:UUD) CEO Gary Phillips speaks to Proactive's Andrew Scott after it was announced its US licensee Chiesi Farmaceutici SpA filed a resubmission to the FDA for Bronchitol® . The move addresses issues raised by the US Food and Drug Administration (FDA)...

on 6/5/20

2 min read