Orion Gains Irish/Hungarian MAs For Bufomix Easyhaler
Orion has received Irish and Hungarian marketing authorisation (MA) for Bufomix Easyhaler (budenoside/formoterol), an inhaled combination product indicated for the treatment of asthma and chronic obstructive pulmonary disease (COPD) in patients aged 12 year and above. In this formulation, budesonide acts as an anti-inflammatory agent and formoterol acts as a long-acting bronchodilator. The MA covers two strengths (budesonide 160mcg/formoterol 4.5mcg; and budesonide 320mcg/formoterol 9mcg).
The Irish and Hungarian MAs are the first approvals of the EU decentralised procedures for 22 EU countries, in which Sweden acted as a reference member state. National approval procedure of the MA applications is ongoing in following EU countries: Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, Greece, Italy, Latvia, Lithuania, Luxembourg, Malta, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden. In addition, national procedures are ongoing in Iceland, Norway and Switzerland.
Orion's Easyhaler is an in-house developed dry-powder inhaler. Orion has developed Easyhaler-adapted dry-powder formulations of a number of generic active substances used in the treatment of asthma and COPD, such as salbutamol, beclometasone, budesonide and formoterol. Orion is currently developing a combined formulation of fluticasone and salmeterol for the treatment of asthma and COPD.