Pharmaxis said it received a so-called complete response letter from the U.S. Food and Drug Administration saying the application for its lung-function test Aridol couldn’t be approved in the present form.
US FDA cited deficiencies at three manufacturing and testing subcontractors, a labeling issue and post-marketing requirements, Pharmaxis said in a statement.
“Importantly, we have not been requested to undertake any additional clinical studies prior to product approval,” stated Pharmaxis Chief Executive Officer Alan Robertson.
Pharmaxis will address the issues and seek approval as soon as possible, Robertson said.
Aridol is approved for sale in Australia, major European countries, Korea.
Pharmaxis has filed a New Drug Application (NDA) for the approval of Aridol in the United States in March.
In November, the Advisory Committee of the U.S. Food and Drug Administration (FDA) voted to recommend the approval of Aridol for use as a bronchial test to assess bronchial hyperresponsiveness to aid in diagnosing patients who have symptoms of asthma or symptoms that are suggestive of asthma.
Aridol is designed to help doctors diagnose and manage asthma by detecting active airway inflammation through measuring airway hyper-responsiveness.
By having patients inhale Aridol via a simple hand-held device, doctors can determine the severity of a patient’s inflammation and prescribe the right amount of medication to bring it under control.
Aridol is the first and only approved Europe-wide lung function test and the world’s first approved indirect challenge test for asthma, a condition which affects 52 millions people worldwide, Pharmaxis said in a press release.
Aridol is involved in investigator-sponsored clinical trials worldwide, treating thousand of patients.
Aridol has also been included in both international and Australian official guidelines for managing asthma.
Pharmaxis is a specialty pharmaceutical company involved in the research, development and commercialisation of new therapies for respiratory diseases.
Pharmaxis therapeutic interests include lung diseases such as cystic fibrosis, bronchiectasis and asthma; as well as chronic obstructive pulmonary diseases such as chronic bronchitis and pulmonary fibrosis.
Pharmaxis first product, Aridol, is designed to identify twitchy or hyper-responsive airways and to assist in diagnosing and managing asthma.
Pharmaxis second product, Bronchitol is designed to restore normal lung hydration, improve lung function and to help relieve the mucus burden in the lungs of patients suffering from chronic respiratory conditions.
Bronchitol has completed the first regulatory Phase 3 clinical trials in both cystic fibrosis and bronchiectasis.
Headquartered in Sydney at its TGA-approved manufacturing facilities, Pharmaxis has offices in four continents.