Mynzepli® Achieves European Approval – A Major Milestone
Mynzepli® Achieves European Approval – A Major Milestone
Mynzepli® (aflibercept) has successfully received approval across all European Economic Area member countries for treating various retinal diseases, including neovascular (wet) age-related macular degeneration (AMD). This approval represents a significant step forward in enhancing patient access to effective therapies.
The Basis of Approval
The approval of Mynzepli® is the result of rigorous analytical, non-clinical, and clinical similarity studies. Notably, this includes a confirmatory efficacy study that demonstrated the equivalency of Mynzepli® to the reference biologic, Eylea®, in patients suffering from neovascular AMD.
Quotes from Key Leaders
Joseph McClellan, Chief Scientific and Technical Officer of Alvotech, emphasized the importance of the approval, stating, "Timely access to effective therapies is essential for individuals affected by retinal diseases. With millions of Europeans impacted, the approval of Mynzepli represents important progress in providing innovative and affordable treatment options. This ensures that patients throughout Europe have improved access to vision-preserving care, regardless of financial or logistical barriers."
In addition, Nick Warwick, the Chief Medical Officer of Advanz Pharma, remarked, "The approval of Mynzepli® marks an important milestone in our mission to broaden access to high-quality and affordable medicines for patients across Europe." This sentiment highlights the commitment both companies have towards improving healthcare outcomes.
Details of the Approval
The centralized marketing authorization for Mynzepli® is valid in all EEA countries, which includes the 27 EU member states, as well as Norway, Iceland, and Lichtenstein. The global sales figures for Eylea® were approximately $9 billion in the previous year, with a significant portion generated in Europe. This demonstrates the considerable market potential and the need for affordable alternatives.
Clinical Applications of Mynzepli®
Mynzepli® is approved for several adult indications that parallel those of the reference biologic. These include treatment for neovascular (wet) AMD and visual impairment due to macular edema stemming from retinal vein occlusion, diabetic macular edema, or myopic choroidal neovascularization. It will be introduced as a 40 mg/mL solution for injection, available in both pre-filled syringes and vials.
Future Developments
Earlier this year, Alvotech announced positive preliminary results from a clinical study involving AVT06, the biosimilar candidate to Eylea®. This study successfully met its primary endpoint, establishing the therapeutic equivalence of the biosimilar to the original Eylea®. The approval from the European Commission followed the positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use.
The Significance of Mynzepli®
Mynzepli® (aflibercept) is a recombinant fusion protein that serves as an essential therapy by binding to vascular endothelial growth factors (VEGF). This action inhibits VEGF receptors' activation, thereby reducing neovascularization and vascular permeability. Thus, its approval signifies a crucial advancement in the treatment landscape for retinal diseases.
About Alvotech and Advanz Pharma
Alvotech is dedicated to leading in the biosimilar space, focusing on high-quality, cost-effective products. Their mission extends globally, with partnerships aimed at improving access to specialized medications across various therapeutic areas. Additionally, Advanz Pharma’s commitment lies in enhancing patients' lives through its diverse portfolio of specialty, hospital, and rare disease medicines. With their established commercial presence in over 90 countries, Advanz Pharma continues to strive for excellence in pharmaceutical innovation.
Frequently Asked Questions
What is Mynzepli® used for?
Mynzepli® is approved for treating various retinal diseases, including neovascular (wet) age-related macular degeneration and visual impairment due to retinal vein occlusion.
Who developed Mynzepli®?
Mynzepli® was developed by Alvotech in collaboration with Advanz Pharma.
What distinguishes Mynzepli® from Eylea®?
Mynzepli® is a biosimilar to Eylea®, meaning it is designed to be therapeutically equivalent while offering potentially more affordable treatment options.
Where was Mynzepli® approved?
Mynzepli® received approval in all member countries of the European Economic Area, covering most of Europe.
How does Mynzepli® work?
Mynzepli® works by inhibiting the binding and activation of vascular endothelial growth factors, reducing neovascularization and vascular permeability.
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