Teva Pharmaceutical Industries announced that it has received marketing authorization from the European Commission for DuoResp Spiromax as treatment for asthma and chronic obstructive pulmonary disease (COPD).
DuoResp Spiromax is a multi-dose dry powder inhaler containing a Fixed Dose Combination (FDC) of its active ingredient budesonide and formoterol fumarate dihydrate. Budesonide is an inhaled corticosteroid implicated to treat the inflammation in asthma and COPD. Formoterol fumarate dehydrate is a beta2 agonist indicated to relieve symptoms of bronchoconstriction in asthma and COPD.
Rob Koremans, President and CEO of Teva Global Specialty Medicines, said, “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.”
Asthma affects 30 million people in Europe and is responsible for an estimated 82,000 hospital admissions per year. COPD afflicts 23 million in Europe and accounts for 1.1 million hospital admissions every year. Together, the diseases cost more than 80 billion euros every year in hospital costs.
Asthma and COPD are controlled by inhaled corticosteroids and long-acting beta-agonists. However, the company said a significant percentage of inhaler users worldwide have inadequate inhaler technique and high errors in inhalation.
The Spiromax inhaler has also been demonstrated to be therapeutically equivalent to the standard budesonide/formoterol combination.
The company announced that two Phase III trials in patients with persistent asthma are currently underway in Europe to compare benefits of DuoResp Spiromax and a budesonide/formoterol multi-dose dry powder inhaler. Results of the studies are expected this year.