The Danish Health and Medicines Authority has granted marketing authorisation to Alimera Sciences' Iluvien for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
With Norway's approval earlier this month, Denmark is the second country to grant national marketing authorisation following the positive outcome in June of the Repeat-Use Procedure application. In addition to Denmark, Iluvien is now approved for marketing in Austria, France, Germany, Italy, Norway, Portugal, Spain and the United Kingdom, and is commercially available in the United Kingdom and Germany. Iluvien is pending approval in an additional eight countries included in the Repeat-Use Procedure application. These countries are Belgium, the Czech Republic, Finland, Ireland, Luxembourg, the Netherlands, Poland and Sweden. A new drug application for Iluvien is currently under review by the US Food and Drug Administration.
"With Iluvien now approved for marketing in the second Scandinavian country, more patients can gain access across Europe to the only three-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 authorisations."
In the Mutual Recognition Procedure (MRP), a medicine is first authorised in one European Union Member State, in accordance with the national procedures of that country. A Marketing Authorisation Holder can use the MRP for the same authorisation more than once after completion of a first decentralised procedure (DCP) and obtain marketing authorisation in other Member States. According to the European Commission Directive guidance, this is known as Repeat-Use, and is a procedure where those Member States, not involved in the first DCP, agree to recognise the validity of the original, national marketing authorisation. The initial Iluvien DCP resulted in marketing authorizations in Austria, France, Germany, Italy, Portugal, Spain and the United Kingdom. Iluvien is currently commercially available in the United Kingdom and Germany.
Iluvien (190 micrograms intravitreal implant in applicator) is a sustained release intravitreal implant used to treat vision impairment associated with chronic DME considered insufficiently responsive to available therapies. Each Iluvien implant provides a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of fluocinolone acetonide (FAc). Iluvien is injected in the back of the patient's eye to a position that takes advantage of the eye's natural fluid dynamics. The applicator employs a 25-gauge needle, which allows for a self-sealing wound. In the FAME Study, a phase 3 clinical study of Iluvien, the most frequently reported adverse drug reactions included cataract development and increased ocular pressure. Iluvien has not been approved for sale in the United States.
Alimera Sciences, Inc., headquartered in Alpharetta, Georgia, is a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals.