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Altana asthma drug gets additional European OK

Altana's inhaled corticosteroid Alvesco has gained an additional European approval in the treatment of mild to severe persistent asthma in adolescent patients ages 12 and older.

Alvesco (ciclesonide) is an inhaled corticosteroid with novel release and distribution properties that result in lung-targeted anti-inflammatory effects. The product is currently approved in 35 countries worldwide for the treatment of persistent asthma, and is available in 15 countries, including Germany, the UK, Australia, and Brazil.

The drug is part of Altana’s ciclesonide platform, which also includes a nasal spray in phase III development and a fixed combination product with long-acting beta-agonist formoterol, which is in phase II development.

“We’re delighted that we can now make Alvesco available as an innovative therapy option even to adolescent asthma patients,” said Dr Hans-Joachim Lohrisch, president and CEO of Altana Pharma. “This extended approval will strengthen the Alvesco opportunity.”

Additional market launches are planned for the first half of 2006 and a new drug application (NDA) for Alvesco has been filed with the FDA seeking US approval.