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Pharmaxis Ltd

Pharmaxis prepares for advisory committee meeting on use of Bronchitol in the US

The US Food and Drug Administration has convened a meeting of the Pulmonary-Allergy Drugs Advisory Committee on May 8, 2019.

Scientists in a laboratory
Pharmaxis has a portfolio of products at various stages of development and approval

Pharmaxis Ltd (ASX:PXS) is preparing for an important meeting that will make recommendations on the possible use of its Bronchitol® product for adult cystic fibrosis patients in the United States.

The company is supporting its licensee Chiesi Group in preparing for a meeting with the Pulmonary-Allergy Drugs Advisory Committee (PADAC) which will take place in May.

Chiesi, which is responsible for the regulatory approval process, has been advised by the US Food and Drug Administration (FDA) that the PADAC meeting will take place in the US on May 8.

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Pharmaxis is an Australian pharmaceutical research company focused on inflammation and fibrosis. It has a portfolio of products at various stages of development and approval.

One of these products, Bronchitol, for treatment of cystic fibrosis, is marketed in Europe, Russia and Australia and the company is seeking to market it in the large US market.

As part of this process, Chiesi resubmitted the Bronchitol New Drug Application to the FDA in December of 2018.

Used in treatment of cystic fibrosis patients

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.

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PADAC, which is convened by the FDA, reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of pulmonary disease and diseases with allergic and/or immunologic mechanisms.

Through this process, PADAC makes appropriate recommendations to the Commissioner of Food and Drugs in the US.

The committee comprises a core of 11 voting members including the chair.

These members are selected by the Commissioner from among authorities knowledgeable in the fields of pulmonary medicine, allergy, clinical immunology, and epidemiology or statistics.

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Price: 0.195 AUD

Market: ASX
Market Cap: $76.96 m
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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