German drugmaker Altana said on Friday its asthma drug Alvesco has had its labelling extended in the European Union to include the treatment of severe persistent asthma in adolescent patients as young as 12.
Alvesco (ciclesonide) is currently approved in 35 countries worldwide for persistent asthma, and has been launched in 15 countries. But the inhaled corticosteroid – one of two key new products that the company has developed to reduce its reliance on top-selling gastrointestinal drug pantoprazole – has not grown as fast as expected.
The company also suffered another major blow when it was forced to withdraw a European marketing application for chronic obstructive pulmonary disease (COPD) drug Daxas (roflumilast) in November 2005.
Once tipped as a potential blockbuster, Alvesco had sales of 8 million euros ($10m) last year, at the bottom end of Altana’s expectations, in the face of the continuing emergence of combination treatment for asthma using products such as GlaxoSmithKline’s Seretide/Advair (salmeterol and fluticasone) and AstraZeneca’s Symbicort (budesonide and formoterol).
Meantime, Alvesco’s growth has also been held back by a delay in bringing it to market in the USA. The US Food and Drug Administration sent Altana an ‘approvable’ letter for the product in October 2004, requesting clinical data from an ongoing trial, and Altana has not predicted when it might expect approval.