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ALVESCO(R) Gains FDA Approval for the U.S. Market
Date:1/16/2008

ernational Marketing.

About ALVESCO(R)

ALVESCO(R) (ciclesonide) Inhalation Aerosol is a new generation of inhaled corticosteroid that reduces inflammatory processes and is indicated for the use in patients with asthma. ALVESCO(R) has been approved in 45 countries including the U.S. and introduced in 30, with more launches expected in 2008.

ALVESCO(R) 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(R) has wide inhibitory activities against multiple inflammatory cell types and chemicals involved in the asthmatic response.

Inhaled corticosteroids (ICS) are regarded today as the gold standard in asthma and allergic rhinitis therapy. They inhibit the activity of pro-inflammatory cells and promote the endogenous production of anti-inflammatory substances. With regular use of these corticosteroids, the inflammation in the lungs and airways that underlies the asthma is attenuated.

In clinical trials, ALVESCO(R) 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.

Treatment with orally inhaled corticosteroids may lead to signs or symptoms of hypercorticism, suppression of hypothalamic-pituitary-adrenal (HPA) function and/or suppression of growth in children. Glaucoma, increased intraocular pressure and cataracts have been reported following the administration of inhaled corticosteroids.

ALVESCO(R) (ciclesonide) Inhalation Aerosol is an orally inhaled corticosteroid indicated for the maintenance treatment of asthma as prophylactic therapy in adult patients 12 years of age and older. ALVESCO(R) is NOT indicated for the relief of acute bronchospasm.

About Asthma


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SOURCE Nycomed International Management GmbH
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