Bayer Submits Application to EMA for Eylea (Aflibercept) Pre-filled Syringe; Included in China's National Reimbursement Drug List Since January 2020
Jan 26, 2020 17:04
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17:04
Bayer
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European Medicines Agency
The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), located in London. It began operations in 1995. The agency is responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. By ensuring that all medicines available on the EU market are safe, effective, and of high quality, the EMA protects public and animal health in the 28 EU Member States and countries of the European Economic Area.
January 26, 2020 News /BioValleyBIOON/ -- German pharmaceutical giantBayer(Bayer) recently announced that it has submitted an application to the European Medicines Agency (EMA) seeking approval for the pre-filled syringe formulation of Eylea® (aflibercept, intravitreal injection solution) for the treatment of five retinal diseases. Currently, Eylea is supplied in vials, requiring physicians to draw the medication into a syringe prior to administration. If this pre-filled syringe is approved, it will provide clinicians with a new treatment option and reduce the preparation steps required for intravitreal injections. In the United States, Regeneron obtained approval in August 2019 forFDAApproval of the Eylea Pre-filled Syringe.
Dr. Michael Devoy, Chief Medical Officer and Head of Medical Affairs and Pharmacovigilance for Bayer’s Pharmaceutical Division, stated, “For many patients suffering from retinal diseases and associated visual impairments, Eylea is a proven effective treatment option. Both in randomized clinical studies and in real-world clinical settings, Eylea has consistently demonstrated excellent outcomes in reducing preventable vision loss. Bayer is committed to further strengthening its therapeutic portfolio through the introduction of pre-filled syringes.”
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 functions as a soluble decoy receptor for members of the VEGF family (including VEGF-A) and placental growth factor (PlGF), exhibiting high affinity for these factors, thereby inhibiting their binding to endogenous VEGF receptors. Consequently, Eylea inhibits 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; meanwhile, 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 over 100 countries worldwide, primarily for the treatment of vision impairment caused by retinal diseases, including:DiabetesDiabetic 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 China, Eylea® (aflibercept) is the first anti-VEGF drug approved for the treatment of diabetic macular edema (DME). The recommended dose is 2 mg, administered as one intravitreal injection per month for the first 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® (Aflibercept) 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 one of the best-selling products globally, with worldwide sales reaching $6.746 billion in 2018. The drug was co-developed by Regeneron and Bayer; Regeneron holds exclusive rights for the U.S. market, while Bayer has been granted exclusive marketing rights in countries and regions outside the United States. Since its global launch, approximately 30 million vials of Eylea have been sold, accumulating 4 million patient-years of treatment experience. (Bioon.com)