Novartis' Foradil gains FDA approval for the treatment of chronic obstructive pulmonary disease (COPD)

28-Sep-2001

Novartis announced today that its fast-acting, long-lasting bronchodilator Foradil® Aerolizer™ (formoterol fumarate inhalation powder) has received approval from the US food and Drug Administration (FDA) for long term administration in the maintenance treatment of bronchoconstriction in patients with COPD, including chronic bronchitis and emphysema. This is a new indication for Foradil, which gained approval from the FDA in February for use in the maintenance of asthma and prevention of exercise-induced bronchospasm.

"This second US approval for Foradil within a year is important for Novartis, as the long-acting beta2-agonist is a key product in our respiratory portfolio," said Thomas Ebeling, CEO of Novartis Pharma AG. "Foradil provides COPD patients with better 24-hour symptom relief compared with the current gold standard treatment, ipratropium bromide, and allows patients to be less dependent on rescue medications."

In the USA, 16 million people have been diagnosed with COPD, but it is estimated that twice as many - 30 to 35 million - could be affected. It is a slowly progressive disease that causes irreversible damage to the lungs, including chronic bronchitis and emphysema. Symptoms include shortness of breath, cough and sputum production.1 The main risk factor for COPD is smoking. COPD is the world's fourth-biggest cause of death, killing about the same number of people per year as HIV/AIDS, according to the World Health Organisation.

Foradil is already available in 87 countries around the world and is recognised by national and international clinical guidelines as a highly effective treatment for COPD and asthma.

https://www.chemeurope.com/en/news/5006/novartis-foradil-gains-fda-approval-for-the-treatment-of-chronic-obstructive-pulmonary-disease-copd.html