Orion to apply for EU approval of new Easyhaler product

Orion has announced plans to file for European regulatory approval of a new addition to the inhalable Easyhaler drug product family.

The pharmaceutical company has been developing an innovative new formulation that combines budesonide as an anti-inflammatory agent with the long-acting bronchodilator formoterol.

Pharmacokinetic studies have shown that this combination therapy can offer benefits in the treatment of asthma and chronic obstructive pulmonary disease (COPD), making it a potentially valuable new Easyhaler option.

Orion expects to submit a marketing authorisation application to the European Medicines Agency during the first half of 2013.

The company has been working with Nycomed since last year to co-market the Easyhaler product range across Europe, leveraging the expertise of both organisations in the field of respiratory disease.

In the UK, Orion retains exclusive marketing rights to the therapies, while the firms are adopting a collaborative approach in other major EU nations such as France, Spain, Germany and Italy.