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news.Altana AG has said that the FDA has granted marketing approval for Omnaris, a once-daily treatment of nasal symptoms associated with allergic rhinitis.
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Omnaris is an intranasal corticosteroid containing ciclesonide as active substance. It is indicated for the treatment in patients 12 years of age and older. In addition, the FDA determined Omnaris approvable for the indication in children ages two to eleven years of age.
Intranasal corticosteroids work by reducing inflammation which is the major underlying cause of nasal symptoms.
The market introduction of Omnaris in the US is being planned for 2007 depending on negotiations with external partners.
Based on Ciclesonide Altana Pharma is developing a broader product platform. Besides the nasal spray, Ciclesonide is also the active substance of an inhaled corticosteroid, for the treatment of persistent asthma, under the brand name Alvesco. In addition, the Ciclesonide platform will also include a fixed combination product with a long-acting beta-agonist, currently in phase II of clinical development.
Altana Pharma partners with Sanofi-Aventis in the US and with Teijin in Japan on various Ciclesonide based products.