Products

Date: 2014-11-12

Type of information: Granting of a Market Authorisation in the EU

Product name: Iluvien®

Compound: 190 micrograms fluocinolone acetonide intravitreal implant in applicator

Therapeutic area: Ophtalmological diseases

Action mechanism:

• corticosteroid. Iluvien® (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant that releases sub-microgram levels of fluocinolone acetonide for up to 36 months for the treatment of chronic diabetic macular edema . The implant provides a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of fluocinolone acetonide. 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.

Company: Alimera Sciences (USA - GA)

Disease: chronic diabetic macular edema (DME)

Latest news:

• • On December 1, 2014, Alimera Sciences announced that the Dutch Inspectie voor de Gezondheidszorg (IGZ) has granted marketing authorization in the Netherlands to Iluvien® for the treatment of vision impairment associated with chronic diabetic macular edema considered insufficiently responsive to available therapies. Approval in the Netherlands marks the sixth European approval through the Repeat-Use application procedure and the 14th approval worldwide, including the recent U.S. approval . To date, the drug is now approved for marketing in Austria , Belgium , Denmark , France , Germany , Ireland , Italy , the Netherlands , Norway , Portugal , Spain , Sweden , the United Kingdom and the United States , and is commercially available in the United Kingdom and Germany .
• • On November 12, 2014, Alimera Sciences announced that the Belgian Federal Agency for Medicines and Health Products (FAMHP) has granted marketing authorization to Iluvien® for the treatment of vision impairment associated with chronic diabetic macular edema considered insufficiently responsive to available therapies.
• • On September 26, 2014, Alimera Sciences announced that the FDA has approved Iluvien® for the treatment of diabetic macular edema in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. Alimera currently intends to begin selling Iluvien® in the U.S. in the first quarter of 2015.
• • On September 3, 2014, Alimera Sciences announced that the Swedish Medical Products Agency has granted marketing authorization to Iluvien® for the treatment of vision impairment associated with chronic diabetic macular edema considered insufficiently responsive to available therapies. Sweden is now the tenth country to grant national marketing authorization. Iluvien® is pending approval in an additional seven countries (Belgium, the Czech Republic , Finland , Ireland , Luxembourg, the Netherlands and Poland). A new drug application for Iluvien® is currently under review by the FDA.
• • On July 31, 2014, Alimera Sciences announced that the Danish Health and Medicines Authority has granted marketing authorization to Iluvien® for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
• • On July 28, 2014, Alimera Sciences announced that the Norwegian Medicines Evaluation Board has granted marketing authorization to Iluvien® for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies. Norway is the first country to grant national marketing authorization following the positive outcome in June of the Repeat-Use Procedure application. Additionally, Iluvien® has been approved for reimbursement in Portugal by INFARMED, the marketing authorization body of the Portuguese Ministry of Health . Alimera plans to move forward with commercialization in Portugal in late 2014.
• • On June 30, 2014, Alimera Sciences has announced the positive outcome of the Repeat-Use Procedure for Iluvien® for the treatment of chronic diabetic macular edema (DME) in an additional 10 European Union countries. The initial Iluvien® decentralized procedure resulted in marketing authorizations in Austria , Portugal , the United Kingdom , Germany , France , Spain and Italy. Iluvien® is currently commercially available in the United Kingdom and Germany
• • On June 23, 2014, Alimera Sciences has announced that the Italian Medicines Agency (Agenzia Italiana del Farmaco) has granted marketing authorization to Iluvien® for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.The marketing authorization notice was published on June 18 in the Gazzetta Ufficiale della Repubblica Italiana , the official journal of record of the Italian government. Designated a C Class product in Italy , the drug will be available initially to private paying patients. Alimera is pursuing H Class designation for Iluvien® with the Italian regulatory authorities, which, if granted, would expand patient access to the product. The Italian authorization is the seventh national approval in the EU.
• • On April 14, 2014, Alimera Sciences has announced that its recent resubmission of the New Drug Application (NDA) for Iluvien® has been acknowledged as received by the FDA as a complete class 2 response to the FDA's October 2013 letter and that a Prescription Drug User Fee Act (PDUFA) goal date of September 26, 2014 has been established. In the resubmission, Alimera responded to questions raised in the FDA's October 2013 letter and provided data from Iluvien® patients and from physician experience with the applicator in the United Kingdom and Germany , where Iluvien® is currently commercially available.
• • On January 13, 2014, Alimera Sciences announced that it has begun shipping initial orders of Iluvien® to several United Kingdom National Health Service (NHS) facilities. Additionally, on January 10, 2014 , the first NHS patient received an Iluvien® implant for the treatment of chronic diabetic macular edema (DME).
• • On December 2, 2013, Alimera Sciences has announced that on November 27, 2013 the United Kingdom's National Institute for Health and Care Excellence (NICE) published final guidance for Iluvien®, clearing the path to patient availability through the National Health Service (NHS). Patients who have a pseudophakic eye, meaning the eye has already undergone cataract surgery, will now have greater access to Iluvien® for the treatment of chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
• • On July  24, 2013, Alimera Sciences has reported that the Transparency Commission (Commission de la Transparence or CT) of the French National Health Authority (Haute Autorite de Sante) has issued a favorable opinion for the reimbursement and hospital listing of Iluvien® by the French National Health Insurance for the treatment of chronic diabetic macular edema considered insufficiently responsive to available therapies. In France, patients will be reimbursed for 100% of the cost of Iluvien® under a specific program, Affection de Longue Duree (ALD), for severe chronic diseases, such as diabetes, because Iluvien® provided a "moderate medical benefit" as defined by the Service Medical Rendu (SMR). When comparing the clinical benefit of Iluvien® to existing therapies (Amelioration du Service Medical Rendu or ASMR), the CT rated the product at "level IV". Alimera will now move forward with the next step in the process, which is to determine the price and any reimbursement conditions for Iluvien® in France with the Comite Economique des Produits de Sante or CEPS. To date, six countries – Austria, the United Kingdom, Portugal, France, Spain and Germany –have granted national licenses for Iluvien®. Currently, the drug is sold in the United Kingdom and Germany. The national license for Iluvien® is under review by the Italian government, and the New Drug Application for Iluvien® is under review, but has not been approved, by the FDA.
• • On May 7, 2013, Alimera Sciences has announced that Iluvien® is now commercially available in Germany. In addition, Albert J. Augustin, M.D., professor and chairman of the Department of Ophthalmology, Klinikum Karlsruhe, Karlsruhe, Germany, has treated the world's first patient with the implant injection since the product became commercially available. The patient, a 67-year-old man, was diagnosed with diabetes more than 20 years ago.
• • On January 23, 2013, Alimera Sciences has announced that the United Kingdom 's National Institute for Health and Clinical Excellence (NICE) has published final guidance indicating that Iluvien® is not cost effective for the treatment of chronic diabetic macular edema considered insufficiently responsive to available therapies. This information is consistent with the final draft guidance issued on November 29, 2012 and does not take into account any potential for a patient access scheme (PAS). The NICE Appraisal Committee acknowledged the clinical effectiveness of Iluvien® in the treatment of vision impairment associated with chronic diabetic macular edema considered insufficiently responsive to available therapies, but noted that cost-effectiveness thresholds for the product have not yet been met. Rather than appealing the Appraisal Committee's findings, Alimera has chosen to pursue a simple PAS for Iluvien® that is intended to allow treatment decisions to be based on patient need, rather than cost. The PAS is currently under review by the Patient Access Schemes Liaison Unit (PASLU) at NICE.
• • On January 17, 2013, Alimera Sciences has announced the Spanish Agency of Drugs and Medical Devices (Agencia Espanola de Medicamentos y Productos Sanitarios) has granted marketing authorization to Iluvien® for the treatment of vision impairment associated with chronic diabetic macular edema  considered insufficiently responsive to available therapies. The Spanish authorization is the sixth national approval in the EU, preceded by Austria, the United Kingdom, Portugal, France and Germany.
• • On July 18, 2012, Alimera Sciences has announced that the National Security Agency of Medicines and Health Products (L'Agence Nationale de Sécurité du Médicament et des Produits de Santé) has granted marketing authorization to Iluvien® for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies. The product has now been granted marketing authorizations in four of the seven EU countries in which Alimera has applied.
• • On June 5, 2012, the Portuguese Authority of Medicines and Health Products (Autoridade Nacional do Medicamento e Produtos de Sauce, Infarmed) has granted marketing authorization to Iluvien® for the treatment of vision impairment associated with chronic diabetic macular edema considered insufficiently responsive to available therapies.
• • On May 7, 2012, the Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA) has granted marketing authorization to Iluvien® for the treatment of vision impairment associated with chronic diabetic macular edema considered insufficiently responsive to available therapies.
• • On April 24, 2012, the Austrian Agency for Health and Food Safety (Österreichische Agentur für Gesundheit und Ernährungssicherheit, AGES) has granted marketing authorization to Iluvien® for the treatment of vision impairment associated with chronic diabetic macular edema considered insufficiently responsive to available therapies.
• • On February 28, 2012, Alimera Sciences announced the positive outcome of the Decentralized Procedure (DCP) for Iluvien® in Europe. The announcement follows the issuance of the Final Assessment Report from the Reference Member State (RMS), 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 approvable. The regulatory process will now enter the national phase of the DCP in which the RMS and each CMS grants its national license. The CMS include Austria, France, Germany, Italy, Portugal and Spain. Iluvien® will be indicated for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies. The clinical trial data showed that in patients with chronic DME at month 30, after receiving the Iluvien® implant, 38 percent of patients experienced an improvement from baseline in their best corrected visual acuity on the Early Treatment of Diabetic Retinopathy Study (ETDRS) eye chart of 15 letters or more. At the completion of the 36-month study, 34 percent had achieved the same result. This effect was highly statistically significant as compared to the sham control group, which received laser and other intravitreally administered therapies

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization: 2014-06-29

UE authorization: 2012-02-28

Favourable opinion UE: 2014-09-26

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes