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CHMP backs Teva's DuoResp Spiromax

February 22, 2014 1:46 AM UTC

EMA's CHMP backed approval of DuoResp Spiromax budesonide/formoterol from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) to treat asthma and severe chronic obstructive pulmonary disease (COPD). DuoResp Spiromax is a combination of budesonide, an inhaled corticosteroid, and formoterol, a long-acting adrenergic receptor beta 2 agonist (LABA). The product uses Teva's Spiromax delivery platform, a breath-actuated, dry-powder inhaler that is designed to provide consistent dosing. CHMP also backed approval of the product under the name BiResp Spiromax.

AstraZeneca plc (LSE:AZN; NYSE:AZN) markets Symbicort budesonide/formoterol for asthma and COPD in at least 88 countries worldwide. In the EU, the product uses the pharma's Turbohaler dry powder inhaler. AstraZeneca recorded 2013 Symbicort sales in Europe of $1.5 billion. ...