Iluvien for chronic DME approved for marketing in Denmark, Norway

August 5, 2014

The Danish Health and Medicines Authority, along with the Norwegian Medicines Evaluation Board, have granted marketing authorization to Alimera Sciences’ Iluvien for the treatment of vision impairment associated with chronic diabetic macular edema (DME) in their respective countries.

 

Atlanta-The Danish Health and Medicines Authority, along with the Norwegian Medicines Evaluation Board, have granted marketing authorization to Alimera Sciences’ Iluvien for the treatment of vision impairment associated with chronic diabetic macular edema (DME) in their respective countries.

Denmark and Norway are the first countries to grant national marketing authorization following the positive outcome in June of the Repeat-Use Procedure application.

The treatment is approved for marketing in Austria, France, Germany, Italy, Portugal, Spain, and the United Kingdom. It is also commercially available in the United Kingdom and Germany.

The treatment is pending approval in an additional eight countries included in the Repeat-Use Procedure applications: Belgium, the Czech Republic, Finland, Ireland, Luxembourg, the Netherlands, Poland, and Sweden.

 

A new drug application for the treatment is currently under review by the FDA.

“With (the treatment) now approved for marketing in (Denmark and Norway), more patients can gain access across Europe to the only 3-year treatment for DME, and the only treatment for the chronic form of the disease,” said Dan Myers, Alimera’s president and chief executive officer. “We look forward to continuing to expand our geographic footprint through additional national marketing authorizations.”

 

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