The European Commission has approved Teva’s DuoResp Spiromax budesonide/formoterol DPI for the treatment of asthma and COPD, the company has announced. The EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion regarding the DuoResp Spiromax application in February 2014.
Teva Global Specialty Medicines President and CEO Rob Koremans commented, “We are delighted to receive approval for DuoResp Spiromax. This is a major advance in inhalers – the need for more intuitive devices is critical and has been highlighted by healthcare professionals and patient groups. It is widely accepted that poor or inadequate inhaler technique not only negatively impacts treatment adherence, but means that patients do not obtain the full benefit from their medication.”
The company said that “DuoResp Spiromax has been demonstrated to be therapeutically equivalent to the well-established budesonide/formoterol combination” [Symbicort] and also that two Phase 3 studies comparing DuoResp Spiromax to “a budesonide/formoterol multi-dose dry powder inhaler” for the treatment of asthma should be completed later this year.
Read the Teva press release.
