The UK, acting as the Reference Member State (RMS), and six other EU member states, are reported to have reached agreement for the approval of Iluvien to treat chronic diabetic macular edema (DME). The Marketing Authorisation Application (MAA) was submitted under the EU’s Decentralized Procedure (DCP) and each member state is now expected to conduct a national license process for approval of the product. Iluvien is now expected to be the first sustained release pharmaceutical in the EU for the treatment of DME. Sponsors of the product, Alimera Sciences Inc., stated that the announcement follows the issuance of the Final Assessment Report from the Reference Member State, the Medicines and Healthcare Products Regulatory Agency of the United Kingdom (MHRA), and the agreement of all the Concerned Member States (CMS) that Iluvien is now approvable for chronic DME.
Iluvien to be approved for chronic Diabetic Macular Edema (DME) by the UK, Austria, France, Germany, Italy, Portugal and Spain
- by swdadmin