EU approval for Teva’s DuoResp Spiromax for asthma and COPD

The European Commission has granted marketing authorization for Israel-based Teva Pharmaceutical Industries’ (NYSE: TEVA) DuoResp Spiromaxfor the treatment of patients with asthma and chronic obstructive pulmonary disease (COPD) where the use of a combination of an inhaled corticosteroid and long-acting beta2-adrenoceptor agonist is appropriate.

DuoResp Spiromax is a new, multi-dose dry-powder inhaler containing a fixed dose combination (FDC) of budesonide, an inhaled corticosteroid to treat the underlying inflammation in asthma and COPD, and formoterol fumarate dihydrate, a rapid-acting and long-lasting beta2 agonist for the relief of bronchoconstriction in asthma and COPD.

DuoResp Spiromax will enter the ICS/LABA fixed combination inhaled market segment that has total product sales of $13.9 billion worldwide, and $4.4 billion within Europe, said Teva, the world’s largest generic drugs maker, at the time of a positive recommendation for the European Medicines advisory committee (The Pharma Letter February 22).