Bayer files for approval of extended 6 month treatment interval for Eylea 8 mg in EU
Berlin: Bayer has submitted an application to the European Medicines Agency (EMA) to expand treatment intervals of up to 6 months with Eylea 8 mg (aflibercept 8 mg, 114.3 mg/ml solution for injection) for the treatment of two major retinal diseases, neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME).
The submission is based on positive three-year results from open-label extension studies of the clinical trials PULSAR, in nAMD and PHOTON, in DME. In both extension studies patients randomized to Eylea 8 mg from baseline maintained their visual and anatomic improvements, with 28% of patients in DME and 24% of patients in nAMD having a last assigned dosing interval of 6 months at the end of three years.
“Longer dosing intervals address a critical unmet medical need and offer patients living with retinal diseases greater flexibility and a reduced burden from frequent injections and hospital visits. This is also important to those that care for these patients,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization, and Member of the Pharmaceuticals Leadership Team at Bayer. “Eylea 8 mg was the first anti-VEGF to receive a 5-month label in the EU, and the new data support a substantial proportion of patients have the potential to maintain 6-month extended treatment intervals.”
The safety profile of Eylea 8 mg continued to be favorable in the third year in both studies and is consistent with the well-established safety profile of Eylea 2 mg. The long-term safety data did not show any new signals in both trials, including patients switching from Eylea 2 mg to Eylea 8 mg. The rates for ocular treatment emergent adverse events were similar in all treatment groups.
Eylea 8 mg (aflibercept 8 mg) has been approved to date in more than 50 markets for the treatment of nAMD and DME. Further regulatory applications for Eylea 8 mg in additional markets are ongoing.
Eylea 8 mg (aflibercept 8 mg; in the United States: Eylea HD) is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to Eylea 2 mg (aflibercept 2 mg) and Eylea HD in the United States. Bayer has licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of Eylea 2 mg and Eylea 8 mg.
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