Iluvien Update 5: European Approval on the Horizon
Finally, some good news for Alimera (and pSivida). A few days ago, the company announced that it had received a positive outcome to the Decentralized Procedure (DCP) for Iluvien in Europe. Iluvien is now expected to be the first sustained release pharmaceutical in the European Union for the treatment of diabetic macular edema (DME).
The regulatory process will now enter the national phase of the DCP in which the Reference Member State (RMS), the Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA), and each Concerned Member States (CMS) grants its national license. The CMS include Austria, France, Germany, Italy, Portugal and Spain.
While it appears that this drug for DME is not going to be moving forward in the US (see Update 4: FDA Turns Down Alimera’s NDA for Approval of Iluvien Again), approval for marketing in Europe appears on track. It has been estimated that the European market may be the same size as the US market.
Just for reference, Iluvien is licensed by Alimera from pSivdia.
For more on the background of this unique sustained release drug for the treatment of retinal disease, please see my original report on the product, and the four updates, listed (and linked) at the end of this writeup.
Here are excerpts from the twin press releases issued by both Alimera and pSivida:
Alimera Sciences, Inc., a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today 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 International Diabetes Federation estimates that, in these seven countries alone, 22.1 million people are currently living with diabetes. By comparison, the Centers for Disease Control and Prevention estimate that Americans with diabetes now number 25.8 million. Alimera estimates that within the seven CMS countries, 1.2 million people suffer from DME.
"Achieving a favorable conclusion for Iluvien in Europe is a significant milestone for Alimera and very encouraging for the many patients with this challenging chronic disease," said Dan Myers, president and chief executive officer, Alimera Sciences. "We will continue to work closely with the UK and the Concerned Member States to ensure that Iluvien is made available to patients as soon as possible."
Iluvien is Alimera's sustained release intravitreal implant that releases sub-microgram levels of fluocinolone acetonide (FAc) for up to 36 months for the treatment of chronic DME. 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.
"Our market research indicates that, given DME is a leading cause of blindness in working-age adults, there is a significant opportunity for an effective ophthalmic drug to treat patients insufficiently responsive to available therapies," said Dave Holland, senior vice president of sales and marketing, Alimera Sciences. "An effective, truly long-term treatment option could have a very positive impact on the quality of life for patients with this chronic debilitating disease."
In July 2010, the Marketing Authorization Application (MAA) was submitted to seven European countries via the DCP with the UK MHRA as the RMS. The MAA included data from two Phase 3 pivotal clinical trials (collectively known as the FAMET Study) for Iluvien conducted by Alimera. The trials involved 956 patients in sites across the United States, Canada, Europe and India to assess the efficacy and safety of Iluvien for the treatment of DME. Based on a consensus arrived upon by the RMS and the CMS, the MHRA issued its Final Assessment Report that Iluvien is approvable.
About the FAMET Safety
Safety was assessed among those patients treated with Iluvien who were in the subgroup of patients with DME for three years or more and were considered to have chronic DME. Intraocular pressure (IOP) increases to 30 millimeters of mercury (mmHg) or greater at any time point were seen in 12.7% of these patients by month 36, compared to 18.4% in the full Iluvien treated patient population. By month 36, 3.6% of these patients had undergone an incisional surgical procedure to reduce elevated IOP, compared to 4.8% in the full patient population. The incidence of cataracts among patients with a natural lens in their eye at the start of the study was 84.1% at month 36, with 87.3% undergoing a cataract operation, compared to 81.7% and 80%, respectively, in the full patient population.
And, the release from pSivida:
pSivida Corp., a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced the positive outcome of the Decentralized Procedure (DCP) for the approval of Iluvienr in Europe. The announcement follows the issuance of the Final Assessment Report to pSivida's licensee, Alimera Sciences, Inc. 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.
"I'm very pleased about this favorable outcome of the EU regulatory process for Iluvien," said Paul Ashton, president and chief executive officer of pSivida.
Iluvien is an injectable, sustained-release intravitreal insert that releases sub-microgram levels of fluocinolone acetonide (FAc) for up to 36 months for the treatment of chronic DME. pSivida is developing an insert of the same design for the treatment of uveitis affecting the posterior of the eye.
Previous Iluvien Writeups:
posted by Irv Arons @ 5:03 PM
0 comments
0 Comments:
Post a Comment
<< Home