Bayer holds the rights to Eylea (aflibercept) outside of the US, while Regeneron possesses the US rights and shares the profits of sales made by the former company.
After Regeneron succeeded in gaining US Food and Drug Administration (FDA) approval for a pre-filled syringe injection form of the drug, Bayer was able to announce that the European Medicines Agency (EMA) had followed suit.
In the US, the process for Regeneron was not a simple one, after having its application knocked back by the FDA, as the agency requested further clinical data and manufacturing information.
Eight months later, the EMA’s approval means that Eylea can be delivered via pre-filled syringe injection for, which “requires fewer steps to prepare compared to the intravitreal injection procedure of the existing vial,” the companies stated.
Eylea will be able to be used in this form of drug delivery to treat patients with various ophthalmic conditions, including age-related macular degeneration, and impaired vision due to macular edema, among others.
The approval builds on clinical trial data that showed patients were able to receive the treatment at extended intervals. In studies, 60% of patients were able to manage their condition with 12-week interval dosing and 40% managed the same at 16-week intervals.