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Pharmaxis licensee receives US FDA guidance on Bronchitol approval steps

The FDA review of the Bronchitol NDA (new drug application) is expected to be completed in the second quarter of 2020.

Pharmaxis Ltd - Pharmaxis licensee receives US FDA guidance on Bronchitol approval steps
Bronchitol is approved and marketed in Europe, Russia, Australia and several other countries

Pharmaxis Ltd’s (ASX:PXS) US licensee Chiesi Group has received a detailed advice from the US Food and Drug Administration (FDA) on the requirements necessary to approve Bronchitol® (mannitol) for the treatment of adult cystic fibrosis patients in the US.

Based on this feedback Chiesi has added an additional month to its timetable. The FDA review of the Bronchitol NDA is therefore now expected to be completed in the second quarter of 2020.

Size of human factor study to be increased

In a Complete Response Letter received by Chiesi in June 2019, the FDA required Chiesi revise the product packaging and user instructions for Bronchitol and then conduct a human factor study (HFS) demonstrating that the revisions would enable healthcare professionals to properly administer the mannitol tolerance test.

Chiesi submitted a protocol for the HFS last quarter to ensure the FDA’s requirements were fully incorporated in the study.

Chiesi has now received the FDA’s advice to increase the size of the HFS as well as other FDA recommendations that have been incorporated into the final study design.

Potential for US$10 million milestone payment

Pharmaxis CEO Gary Phillips said: “This important regulatory step has now been completed and the study can commence.  

“While the timetable has extended by a month, importantly the FDA advice sought and received by Chiesi ensures the HFS is conducted in accordance with the FDA’s expectations.”

Chiesi is responsible for the regulatory approval and commercialisation of Bronchitol in the US.

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

Approved in multiple markets

Pharmaxis will manufacture and be the exclusive supplier of Bronchitol for the US market.

Bronchitol is an inhaled dry powder for the treatment of cystic fibrosis and has been the subject of three large scale global clinical trials conducted by Pharmaxis.

It is approved and marketed in Europe, Russia, Australia and several other countries.

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Pharmaxis hopeful of FDA approval for cystic fibrosis inhalation medicine...

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...

on 13/8/19

2 min read