Orion Corporation has announced that its salmeterol/fluticasone Easyhaler combination DPI has received a positive opinion under the EU’s decentralized procedure, with Sweden as the reference member state. Orion had announced in December 2016 that it planned to submit an MAA in early 2017 based on positive results from a PK study.
According to Orion, it will now begin approval procedures in 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 the United Kingdom.
Orion Senior VP, Pharmaceutical Research and Development Christer Nordstedt commented, “We are satisfied with the favorable 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.”
Orion’s Easyhaler line includes salbutamol, beclomethasone, budesonide, formoterol, and a budesonide/formoterol combination. In 2016, the company announced a deal to co-market the budesonide/formoterol Easyhaler with Menarini in several European countries, and Hikma acquired a license to market the DPI in the MIddle East and North Africa in 2017.
Read the Orion press release.
