Orion announces plan to submit MAA for salmeterol/fluticasone Easyhaler in 2017

Easyhaler maker Orion Corporation has announced that it plans to submit a marketing authorization application in the EU for its salmeterol/fluticasone DPI for the treatment of asthma and COPD in the first half of 2017.

The company said that its plan to submit the MAA is based on recently received positive results from a PK study.

Orion Senior VP, Pharmaceutical Research and Development, and Chief Medical Officer Reijo Salonen commented, “We are extremely satisfied with the favorable results in a challenging development area. Salmeterol-fluticasone combination product will strengthen Orion’s Easyhaler drug product family that by utilziing the same inhaler technology offers diverse treatment options for treatment of asthma and COPD.”

In September 2016, Orion announced that it would co-market its budesonide/formoterol Easyhaler DPI for the treatment of asthma and COPD in Germany, Italy, Spain, and Portugal with Menarini.

Read the Orion press release.

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