ARTICLE | Clinical News

DuoResp Spiromax budesonide/formoterol regulatory update

February 24, 2014 8:00 AM UTC

EMA's CHMP backed approval of DuoResp Spiromax budesonide/formoterol from Teva to treat asthma and severe chronic obstructive pulmonary disease (COPD). The product is recommended for asthma when combination therapy with inhaled corticosteroids plus inhaled, long-acting adrenergic receptor beta 2 agonists (LABAs) is appropriate. For COPD, DuoResp Spiromax is recommended for patients with a history of exacerbations who have symptoms despite regular therapy with long-acting bronchodilators. DuoResp Spiromax is a combination of budesonide, an inhaled corticosteroid, and formoterol, a 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. ...