FDA clears Omnaris for pediatric allergic rhinitis

German drugmaker Altana AG says that the US Food and Drug Administration has granted a new marketing approval for Omnaris (ciclesonide nasal spray), 200mg once-daily. The intranasal corticosteroid is already indicated in the USA for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis in patients 12 years of age and older and the Agency has now cleared the drug in children aged two to 11 years.

The product is Altana's first offering subject to its new out-licensing strategy regarding US commercialization. In this market, introduction of the agent is being planned for 2007 depending on negotiations with external partners. Altana noted that intranasal corticosteroids are considered to be the gold standard for the treatment of allergic rhinitis. They work by reducing inflammation, which is the major underlying cause of nasal symptoms.