Bayer's Eylea (Aflibercept) Prefilled Syringe Approved in Europe for Retinal Diseases, Now Covered by China's National Reimbursement Drug List

April 10, 2020 News /BioValleyBIOON/ --Bayer(Bayer) recently announced that the European Medicines Agency (EMA) has approved a new pre-filled syringe formulation of Eylea® (Eylea®, generic name: aflibercept, aflibercept intravitreal injection solution) for the treatment of five adult retinal diseases. This approval applies to all 27 EU member states, as well as the United Kingdom, Iceland, Norway, and Liechtenstein.

Currently, Eylea is supplied in vials, requiring physicians to draw the medication into a syringe prior to administration. The approval and market launch of this new pre-filled syringe will provide clinicians with a new treatment option, reducing the preparation steps required for intravitreal injections. In the United States, Regeneron obtained in August 2019FDAApproval of Eylea Prefilled Syringe.

Dr. Michael Devoy, Chief Medical Officer of Bayer and Head of Medical Affairs and Pharmacovigilance for Bayer’s Pharmaceuticals Division, stated: “Eylea is the only approvedClinical TrialsAnti-VEGF therapies that have successfully extended the treatment interval to 4 months (16 weeks).“Eylea consistently delivers robust therapeutic outcomes in reducing preventable vision loss. With the approval and market launch of this new pre-filled syringe, Bayer will continue to maintain its leadership in this field, benefiting both physicians and patients.”

Bayer recently announced the results of the Phase IV ALTAIR study, which confirmed the efficacy of the Eylea treat-and-extend (T&E) dosing regimen for wet age-related macular degeneration (wet AMD). These promising results indicate a significant reduction in injection burden, as up to 60% of patients were able to achieve injection intervals of 3 months (12-week intervals) or longer, while over 40% of patients achieved 4-month (16-week interval) injection intervals. Eylea is the only approvedClinical Trialanti-VEGF agents that have successfully extended the treatment interval to 16 weeks in

Eylea is a novel intravitreal VEGF inhibitor, a recombinant fusion protein composed of the extracellular domains of human vascular endothelial growth factor (VEGF) receptors 1 and 2 fused to the Fc fragment of human immunoglobulin G1. Eylea acts as a soluble decoy receptor for members of the VEGF family (including VEGF-A) and placental growth factor (PlGF), binding these factors with high affinity to prevent their interaction with endogenous VEGF receptors, thereby inhibiting abnormal angiogenesis and vascular leakage.

For patients with visual impairment due to various retinal diseases, Eylea is an effective treatment option that has consistently demonstrated favorable therapeutic outcomes in reducing preventable vision loss, both in randomized clinical trials and in real-world clinical settings.

Eylea is the world’s first fully human fusion protein that simultaneously blocks VEGF-A, VEGF-B, and PlGF, offering a broader range of targets; it effectively binds VEGF dimers with higher affinity; furthermore, it has a longer duration of action, providing more sustained efficacy, with injection intervals extendable to 3–4 months.

Currently, Eylea has been approved for five indications in more than 100 countries worldwide, primarily for the treatment of vision impairment caused by retinal diseases, includingDiabetesDiabetic macular edema (DME), neovascular age-related macular degeneration (nAMD), retinal vein occlusion (RVO, including BRVO and CRVO), and vision impairment caused by myopic choroidal neovascularization (myopic CNV).

In late March this year, Eylea was approved in Japan for a new indication: the treatment of neovascular glaucoma (NVG). This approval covers both the vial and pre-filled syringe formulations of Eylea. Notably, Eylea is the first drug globally approved for the treatment of NVG and had previously been granted orphan drug designation for this indication.

In China, Eylea (Aflibercept®) is the first anti-VEGF drug approved for the treatment of DME. The recommended dose is 2 mg, with one injection administered monthly for the initial five months (i.e., five injections), followed by examinations and injections every two months (8 weeks). After 12 months of treatment, the dosing interval may be extended based on visual acuity and anatomical outcomes.

In late November 2019, the National Healthcare Security Administration issued an announcement that Eylea (EYLEA®) would be officially included in the “National Reimbursement Drug List for Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance (2019 Edition)” effective January 1, 2020, with indications including the treatment of adultsDiabetesDiabetic Macular Edema (DME) and Neovascular (Wet) Age-Related Macular Degeneration (nAMD) in Adults.

Eylea is being developed globally through a collaboration between Bayer and Regeneron for the treatment of various retinal diseases. Regeneron retains exclusive rights in the United States, while Bayer holds exclusive marketing rights in countries and regions outside the United States. Since its global launch, approximately 31 million vials of Eylea have been sold, accumulating over 4 million patient-years of treatment experience.

Eylea is one of the best-selling drugs globally, with sales reaching $7.542 billion in 2019, including $4.644 billion from the U.S. market and $2.897 billion from other markets. In January this year, an article titled “Top product forecasts for 2020” published in Nature Reviews Drug Discovery predicted that Eylea’s sales would further climb to $7.916 billion in 2020. (Bioon.com)

Original Source: Bayer launches pre-filled syringe to administer eye medication Eylea in Europe