Teva Pharmaceutical Industries Ltd. announced that they received a positive opinion recommending marketing authorization for DuoResp® Spiromax® (budesonide & formoterol fumarate dihydrate) inhalation powder by The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). With this decision of CHMP, the company could expect a final approval from the European Commisstion (EC) in the next few months.
DuoResp® Spiromax® is a new multi-dose dry-powder inhaler developed for the treatment of chronic obstructive pulmonary disease (COPD) and asthma. The inhaler enables the administration of budesonide in a combination with an inhaled corticosteroid for the treatment of inflammation, and with formoterol fumarate dehydrate, a rapid-acting and long-lasting beta2 agonist for the relief of bronchoconstriction in COPD and asthma.
The features of the product are the improved easiness at use and the consistency at drug delivery from the first dose to the last. It will enter the ICS/LABA fixed combination inhaled market segment which has total product sales of $13.9 billion worldwide and $4.4 billion within Europe.
“The Spiromax inhaler is an important addition to our Respiratory portfolio and supports our strategy to become a leading presence in Respiratory with a robust and differentiated pipeline, projected to be a multi-billion dollar franchise by the end of the decade,” said Michael Hayden, Teva president of Global R&D and chief scientific officer.
Drug development for the treatment of COPD-related diseases, such as emphysema and chronic bronchitis, continue to be a major focus in pharmaceuticals industry. However, particularly with lung-related diseases, drug delivery is an equally important biotechnology, since the manner and efficacy in which new COPD drugs enter the lungs is critical in how effective they are in treating symptoms. Marketing authorization for Teva’s DuoResp® Spiromax® will help to fill escalating needs for new COPD drug delivery options.