Orion Corporation has received positive conclusions for the salmeterol-fluticasone Easyhaler® combination under the EU's decentralized procedures (DCP). The decentralized procedures concern 22 countries, with Sweden acting as the reference member state. National approval procedures of the marketing authorisation applications will start in the following EU Member States: Belgium, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Iceland, Italy, Latvia, Lithuania, Luxemburg, the Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden and United Kingdom. Orion will announce further information on approvals in these countries in its upcoming Interim Reports.
The inhaled salmeterol-fluticasone combined formulation is the sixth member of the Easyhaler® product family intended for the treatment of asthma and COPD. In the combined formulation, the fluticasone acts as an anti-inflammatory agent and salmeterol acts as a long-acting bronchodilator.
"We are satisfied with the favourable results in a challenging development area. The salmeterol-fluticasone combination product will strengthen Orion's Easyhaler® product family that utilizes the same inhaler technology and offers diverse treatment options for treatment of asthma and COPD," says Christer Nordstedt, SVP, Pharmaceutical Research and Development of Orion Corporation.
Orion's Easyhaler® is a dry-powder inhaler developed in-house. Orion has developed Easyhaler-adapted dry powder formulations of several well-known generic active substances (salbutamol, beclometasone, budesonide, formoterol, salmeterol and fluticasone) used in the treatment of asthma and COPD. The previous new product added to the Easyhaler® product family was a combined budesonide-formoterol formulation.
Senior Vice President, Pharmaceutical Research and Development, Orion Corporation
Tel. +358 50 966 2099
Orionintie 1A, FI-02200 Espoo, Finland
Orion is a globally operating Finnish pharmaceutical company - a builder of well-being. Orion develops, manufactures and markets human and veterinary pharmaceuticals, active pharmaceutical ingredients and diagnostic tests. The company is continuously developing new drugs and treatment methods. The core therapy areas of Orion's pharmaceutical R&D are central nervous system (CNS) disorders, oncology and respiratory diseases for which Orion develops inhaled Easyhaler® pulmonary drugs. Orion's net sales in 2017 amounted to EUR 1,085 million and the company had about 3,500 employees. Orion's A and B shares are listed on Nasdaq Helsinki.