Alteogen's EYLUXVI® Achieves European Commission Approval
Alteogen Inc. has reached a pivotal milestone with the recent approval of EYLUXVI® (code name: ALT-L9) by the European Commission (EC). This approval represents the second successful biosimilar for the company, following its earlier launch of the Herceptin® biosimilar through a partnership with Qilu Pharmaceutical. With EYLUXVI®, Alteogen continues its commitment to expanding an innovative biosimilar portfolio.
What is EYLUXVI®?
EYLUXVI® is a biosimilar developed to mirror Eylea®, a well-established treatment for various serious ophthalmic diseases, including wet age-related macular degeneration (wAMD) and diabetic macular oedema (DME). The approval of EYLUXVI® opens new avenues for patients requiring effective therapies, showcasing Alteogen’s advancements in therapeutic solutions.
Regulatory Journey and Clinical Trials
The EC's marketing authorization for EYLUXVI® followed a comprehensive evaluation process that included positive feedback from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). This positive opinion was granted approximately two months before the final approval, underscoring the drug's promising profile.
Alteogen’s clinical trials, which involved 431 patients suffering from wAMD across various countries, were instrumental in demonstrating that EYLUXVI® is therapeutically equivalent to Eylea®. This extensive study illustrated not only the efficacy but also the safety of the biosimilar, giving healthcare providers and patients confidence in its use.
Alteogen's Commitment to Patients
“EYLUXVI® marks our journey into the biosimilars domain through independent research and development. Additionally, this effort was bolstered by our collaboration with Alteogen Biologics,” stated Soon Jae Park, PhD, Chief Executive Officer of Alteogen. This ambitious endeavor highlights Alteogen's dedication not only in advancing research and development but also in navigating the complex approval processes in Europe.
With the marketing authorization now in place, EYLUXVI® is approved throughout Europe for specific indications including wAMD, macular oedema associated with retinal vein occlusion—both branch and central—and myopic choroidal neovascularization (myopic CNV). The diverse applications of EYLUXVI® emphasize the accessible treatment options for patients struggling with these serious conditions.
About Alteogen
Alteogen Inc. is a biopharmaceutical company based in South Korea, established in 2008. It specializes in creating and commercializing innovative biologics, including Antibody-Drug Conjugates (ADCs), biobetters, and biosimilars. Innovative platforms like NexP™-fusion and NexMab™ enhance the development of clinical-stage long-acting therapeutic proteins. Other advancements include the proprietary recombinant human hyaluronidase enzyme, which allows for the effective subcutaneous administration of drugs traditionally given via IV infusion.
Looking Ahead
As Alteogen pushes forward, the new approval of EYLUXVI® marks a significant step in enriching its product lineup and reinforcing its mission to provide effective therapies for significantly impacting patient lives. The company’s future plans would likely include efforts to further enhance drug accessibility and promote healthcare advancements that focus on patient-centered solutions.
Frequently Asked Questions
What is EYLUXVI®?
EYLUXVI® is a biosimilar to Eylea®, developed for the treatment of serious ophthalmic diseases, including wAMD and DME.
What did the European Commission approve?
The European Commission approved EYLUXVI® for marketing, making it accessible for treatment across Europe.
How does EYLUXVI® compare to Eylea®?
Clinical trials demonstrated that EYLUXVI® has equivalent efficacy and safety to Eylea®, confirming it as a viable treatment option.
What is Alteogen's background?
Alteogen Inc. is a biopharmaceutical company focused on the development of biologics, based in South Korea since 2008.
What is Alteogen's commitment to patients?
Alteogen is dedicated to improving patient access to effective therapies and advancing research for serious ophthalmic conditions.
