ALTANA AG announced that the Australian Health Agency (TGA) has granted marketing approval for Alvesco (Ciclesonide) a novel inhaled corticosteroid for the treatment of asthma in adults and adolescents 12 years of age and older. This is worldwide the first approval for Alvesco.
"Alvesco is an innovative inhaled corticosteroid with unique properties that offer an important treatment option for patients with asthma. The approval is a major milestone for ALTANA Pharma and we eagerly anticipate making the product available to patients in other important markets as well", said Dr Hans-Joachim Lohrisch, CEO of ALTANA Pharma.
In the UK, the reference member state for the EU regulatory procedure, we expect the final approval in the near future before mid of the year. Additionally, ALTANA's US partner Aventis applied to the FDA for approval of the asthma drug Alvesco at the end of 2003. ALTANA Pharma and Aventis signed an agreement in 2001 to jointly develop and market Alvesco in the United States. Finally, Teijin has submitted an application for approval for Alvesco in January 2004 in Japan. The cooperation agreement with Teijin was signed in 1998 for marketing Alvesco in Japan.
Alvesco is a new generation inhaled corticosteroid with novel pharmacokinetics properties. Inhaled corticosteroids are considered to be the cornerstone of asthma treatment, and they work by reducing inflammation - the underlying disease process - in the lungs and airways.
Asthma is a chronic lung disease caused by airway inflammation and results in airway constriction in response to certain stimuli. It is characterized by a variety of symptoms including wheezing, coughing and a tightening of the airways, which causes shortness of breath and can be life-threatening. According to the Global Initiative for Asthma (GINA) more than 300 million people worldwide suffer from asthma. The prevalence of asthma is increasing by approximately 50 per cent every decade and worldwide deaths from asthma total more than 180,000 annually.