European Approval Boosts Accessible Treatment with Mynzepli®
Mynzepli® Receives European Approval for Retinal Diseases
Mynzepli® (aflibercept) has achieved a significant milestone by gaining approval across all member countries of the European Economic Area. This remarkable step enables the treatment of various retinal diseases, including neovascular (wet) age-related macular degeneration (AMD), which affects millions of individuals.
Research and Development Behind the Approval
The approval of Mynzepli® is grounded in comprehensive data demonstrating its clinical similarity to Eylea® (aflibercept). A well-designed confirmatory efficacy study compared Mynzepli® directly with Eylea® in patients suffering from neovascular AMD, showcasing the robust capabilities of this biosimilar.
Statements from Key Leaders
Joseph McClellan, the Chief Scientific and Technical Officer at Alvotech, emphasized the urgency for effective therapies for those affected by retinal diseases. He mentioned, "The approval of Mynzepli underscores our commitment to making innovative and affordable treatment options available to patients throughout Europe, circumventing financial and logistical hurdles that may hinder access to care."
Nick Warwick, the Chief Medical Officer of Advanz Pharma, nicely encapsulated the essence of this approval, stating, "Mynzepli® marks a pivotal moment in our goal to enhance access to high-quality and affordable medicines for European patients."
Market Authorization Details
The centralized marketing authorization enables the distribution of Mynzepli® in all EEA countries, encompassing the 27 member states of the European Union, in addition to Norway, Iceland, and Lichtenstein. Notably, sales of Eylea® were around US$9 billion globally in 2024, with one-third of that revenue generated in Europe.
Indications for Use
Mynzepli® is approved for all adult indications that the reference product Eylea® has cleared for use. This includes treatments for neovascular AMD, visual impairment caused by macular edema due to retinal vein occlusion (both branch and central RVO), diabetic macular edema (DME), and myopic choroidal neovascularization (myopic CNV). Patients will be able to receive Mynzepli® as a solution for injection delivered in a pre-filled syringe or vial, both containing 40 mg/mL of the active ingredient.
Clinical Study Success
In January 2024, Alvotech announced encouraging top-line results from a clinical study focused on AVT06, its biosimilar candidate to Eylea®. This study, which evaluated the efficacy, safety, and immunogenicity of AVT06, showed promising results, achieving its primary endpoint—demonstrating therapeutic equivalence between AVT06 and Eylea®.
About Mynzepli® and Its Mechanism
Mynzepli® is classified as a recombinant fusion protein, underscoring its role as a biosimilar to Eylea®. Aflibercept, the active component, works by binding to vascular endothelial growth factors (VEGF), effectively inhibiting the interaction and activation of VEGF receptors. This mechanism plays a crucial role in managing neovascularization and vascular permeability, critical factors in retinal diseases.
About Alvotech
Alvotech is a dedicated biotech enterprise whose focus lies in developing and manufacturing high-quality biosimilar medicines globally. Founded with the vision of becoming a leader in the biosimilar market, Alvotech aims to deliver cost-effective therapeutic options while building robust partnerships across key markets, including the United States, Europe, and Asia.
About Advanz Pharma
Advanz Pharma is committed to enhancing patient lives through the provision of specialty, hospital, and rare disease medicines. With its headquarters in London, Advanz Pharma operates in over 90 countries and is engaged in partnerships with biopharma companies to bring essential medications to patients globally. Their product portfolio spans various therapeutic areas, demonstrating a commitment to innovation and accessibility in pharmaceuticals.
Frequently Asked Questions
What is Mynzepli® approved for?
Mynzepli® is approved for treating various retinal diseases, including neovascular AMD and other conditions related to visual impairment.
How does Mynzepli® compare to Eylea®?
Mynzepli® has been shown to be therapeutically equivalent to Eylea® based on clinical study results and comprehensive similarity data.
What are the available forms of Mynzepli®?
Mynzepli® is available as a 40 mg/mL solution for injection, offered in both pre-filled syringes and vials.
Who are the companies behind Mynzepli®?
Mynzepli® is developed by Alvotech (NASDAQ: ALVO) in collaboration with Advanz Pharma, focusing on providing accessible treatments.
What is Alvotech's mission?
Alvotech strives to be a leader in the biosimilar field by delivering high-quality, cost-effective medicines globally, ensuring patient access to essential therapies.
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