Novartis' Foradil Gains US Approval for the Maintenance Treatment of Asthma

Global Growth Potential Now A Reality for Foradil AerolizerTM Inhaler

20-Feb-2001

Novartis announced today that the US food and Drug Administration (FDA) has approved the fast-acting, long-lasting bronchodilator Foradil® (formoterol fumarate inhalation powder) for the maintenance treatment of asthma and the prevention of bronchospasm in reversible obstructive airways disease (ROAD).

"The US marketing approval of Foradil is an important milestone for Novartis as it is a key growth driver in our respiratory portfolio" said Thomas Ebeling, CEO Novartis Pharma AG. "Patients with asthma in the US can now benefit from Foradil's dual action, which provides both long-lasting symptom control and rapid bronchodilation from a single product."

The US approval is based on the assessment of studies involving more than 7000 patients, including over 1600 mild to moderate asthmatics in 5 key trials. In the studies, Foradil (12mcg) provided patients with clinically significant bronchodilation for a 12-hour period.1 Onset of bronchodilation is similar to the short-acting beta-2-agonist salbutamol.

Foradil is administered twice daily via a dry powder inhaler called the Aerolizer, which unlike traditional metered-dose inhalers provides patients with the reassurance that they are in control of dosing. The Aerolizer offers patients little resistance to inhalation, and produces a whirring noise which signals that the drug is being inhaled. Patients can taste the powder and then open the device to check that they have inhaled all of the dose.

Asthma is a chronic inflammatory lung disease that affects 15 million Americans, and up to 10 times that many around the world. Each year, 180 000 people die from asthma worldwide, according to the World Health Organisation.2 It is characterised by shortness of breath, wheezing, tightness in the chest and a cough that lasts more than a week. Since asthma is a chronic condition, the goal for treatment is management rather than cure.

Foradil is already marketed in 85 countries around the world. Clinical guidelines recognise Foradil as a highly effective treatment for chronic obstructive pulmonary disease (COPD) and asthma.

https://www.chemeurope.com/en/news/1394/novartis-foradil-gains-us-approval-for-the-maintenance-treatment-of-asthma.html