Novartis launches Foradil® Aerolizer™ in the United States

22-May-2001

Novartis announced the US launch of Foradil® Aerolizer™ (formoterol fumarate inhalation powder) a fast-acting long-lasting bronchodilator. Foradil was approved by the US food and Drug Administration in February 2001 for the maintenance treatment of asthma, also known as reversible obstructive airway disease (ROAD).

"We expect the launch of Foradil Aerolizer in the US to have a significant impact on the brand worldwide," said Thomas Ebeling, CEO of Novartis Pharmaceuticals. "Foradil has been improving the quality of life of asthma and COPD patients around the globe for more than 10 years, now patients in the US can experience the same benefits."

Foradil Aerolizer is currently available in 85 countries and has been used for more than two million patient years worldwide. The bronchodilator is delivered with the Aerolizer, a unique easy-to-use, low-resistance, dry-powder inhaler system that provides minimal dose-to-dose variability and enables patients to check if they have inhaled the entire dose of medication.

Foradil provides quick symptomatic relief within five minutes while allowing patients to obtain 12 hours of long-acting bronchodilation, on a recommended dosing of 12 mcg twice daily. A recently published study in the Annals of Allergy, Asthma and Immunology, showed the Foradil Aerolizer to be more effective in improving lung function in patients with asthma compared with albuterol/salbutamol administered via a metered dose inhaler.1,2

Novartis has also filed an NDA with the US Food and Drug Administration for the treatment of chronic obstructive pulmonary disease (COPD), and anticipates approval later this year.

"Clinical trials in over 1600 COPD patients have demonstrated excellent clinical efficacy with Foradil compared to current standard therapy, ipratropium bromide and theophylline, including significant improvements in quality of life," said Mr Ebeling. 3,4

Foradil Aerolizer should not be used to treat acute asthma symptoms. It can be administered concomitantly with, but is not a substitute for, inhaled or oral corticosteroids, which should not be stopped or reduced. Foradil Aerolizer should be used with caution in patients with cardiovascular disorders. Adverse reactions with Foradil Aerolizer are similar to other selective beta2 -agonists, such as tachycardia, nervousness, tremor, muscle cramps, nausea and insomnia.

https://www.chemeurope.com/en/news/3260/novartis-launches-foradil-aerolizer-in-the-united-states.html