Circassia Pharmaceuticals announced that the US Food and Drug Administration has approved DUAKLIR PRESSAIR (aclidinium bromide and formoterol fumarate) for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
DUAKLIR PRESSAIR is a fixed-dose LAMA/LABA combination of the long-acting muscarinic antagonist (LAMA) aclidinium and the long-acting beta agonist (LABA) formoterol. It is administered twice daily via the pre-loaded, breath-actuated, PRESSAIR® multi-dose inhaler.1 The product is approved worldwide, including in the European Union, under a number of brand names.
In April 2017, Circassia and AstraZeneca established a commercial collaboration in the United States under which Circassia has exclusive US commercialization rights to DUAKLIR PRESSAIR and AstraZeneca is responsible for the product’s development and regulatory submission.
“Our collaboration with AstraZeneca throughout the DUAKLIR PRESSAIR regulatory process has been overwhelmingly positive,” said David Acheson, Senior Vice President, US Commercial, Circassia. “We look forward to bringing DUAKLIR PRESSAIR to market in the coming months as an important expansion of Circassia’s COPD and respiratory health portfolio.”
“The FDA approval of DUAKLIR PRESSAIR gives COPD patients a new, effective and safe option in LAMA/LABA therapy, enabling them to receive maximal improvement in lung function delivered through a unique dry-powder inhaler,” said Michael Asmus, Vice President, US Medical Affairs, Circassia.
COPD (chronic obstructive pulmonary disease) is a progressive disease associated mainly with tobacco smoking, air pollution or occupational exposure, which makes it hard to breathe and results in increased episodes of breathlessness.2,3 According to the American Lung Association, COPD is the third leading cause of death in the United States. More than 11 million people have been diagnosed with COPD, but millions more may have the disease without knowing it.4 COPD causes serious long-term disability and early death, and the number of people dying from COPD is growing.4
The most common symptoms of COPD are breathlessness (or a “need for air”), chronic cough, and sputum (mucus) production.3 Sufferers also frequently experience exacerbations, that is, serious episodes of increased breathlessness, cough and sputum production that last from several days to a few weeks.3 These episodes can be seriously disabling and result in the need for urgent medical care (including hospitalization) and sometimes death.
Source: Company Press Release