FDA-approved asthma hits the US market

Swiss pharmaceutical company Nycomed has won FDA approval to market an inhalation drug in the US, which helps to control asthma in patients.

The ALVESCO (ciclesonide) Inhalation Aerosol is a prophylactic therapy that is suitable for patients aged 12 years and older.

It is based on the active ingredient ciclesonide, which is Nycomed's patented corticosteroid with a novel principle of action. Ciclesonide is a prodrug that is activated by intracellular esterases following oral inhalation. ALVESCO has wide inhibitory activities against multiple inflammatory cell types and chemicals involved in the asthmatic response.

"The approval of ALVESCO provides a new and effective treatment option to help patients control their asthma and improve their quality of life, and will be an important treatment option for physicians," said Myron Zitt, MD, chief of allergy and immunology at the Queens Long Island Medical Group in Babylon, New York and clinical associate professor of medicine at the State University of New York, Stony Brook, School of Medicine.

In clinical trials, ALVESCO was generally well tolerated. The most common adverse reactions (>3%) were headache, nasopharyngitis, sinusitis, pharyngolarynegeal pain, upper respiratory infection, arthralgia, nasal congestion, pain in the extremities and back pain.

ALVESCO is patent protected until 2017.