Positive CHMP opinion for Teva’s DuoResp Spiromax for asthma and COPD

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for Israel-based Teva Pharmaceutical Industries (NYSE: TEVA) DuoResp Spiromax (budesonide & formoterol fumarate dihydrate) inhalation powder, a generic version of AstraZeneca's Symbicort.

The recommendation is for the treatment of patients with asthma and chronic obstructive pulmonary disease (COPD) when a combination inhaled corticosteroid and long-acting beta2-adrenoceptor agonist is appropriate. This CHMP decision creates a path forward for a final approval decision from the European Commission that is expected in the next few months.

DuoResp Spiromax is a new multi-dose dry-powder inhaler with a combination 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. The Spiromax inhaler uses unique breath-actuated technology to deliver a consistent dose of the medicines from the first dose to the last.