Bayer-Regeneron Aflibercept 8 mg recommended for EU approval for third retinal indication
Berlin: Bayer has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended aflibercept 8 mg (114.3 mg/ml solution for injection) for marketing authorization in the European Union (EU) for the treatment of patients with visual impairment due to macular edema following retinal vein occlusion (RVO) including branch, central and hemiretinal vein occlusion.
The European Commission’s decision is anticipated within the coming weeks, which would mark the third indication for Eylea 8 mg.
“Following the approval of Eylea 8 mg for treatment intervals of up to six months in neovascular age-related macular degeneration and diabetic macular edema in the EU, this recommendation marks a significant step towards advancing the treatment of retinal vein occlusion. Aflibercept 8 mg is set to enhance the standard of care, reducing the burden of frequent injections and clinic visits for patients experiencing macular edema due to retinal vein occlusion, without compromising efficacy and safety,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer.
The QUASAR clinical study met its primary endpoint at week 36, demonstrating that patients receiving aflibercept 8 mg every 2 months (after 3 or 5 initial monthly injections) achieved non-inferior visual acuity gains and robust fluid control compared to those receiving Eylea 2 mg (aflibercept 2 mg) monthly. Additional submitted data show that visual acuity was maintained with aflibercept 8 mg, and unparalleled durability was demonstrated through the end of the study at week 64. More than 60% of patients receiving aflibercept 8 mg were able to extend their treatment intervals to four months and longer, with 40% having a last assigned interval of five months.
The number of injections, a key secondary endpoint, was significantly reduced to 8.4 injections with aflibercept 8 mg administered every two months (after three initial monthly injections), compared to 11.7 with Eylea 2 mg by week 64. Importantly, fluid reduction – an indicator of disease control – was similar with extended dosing intervals of aflibercept 8 mg compared with dosing intervals of Eylea 2 mg. Additionally, aflibercept 8 mg was well tolerated, and its safety profile was consistent with results from previous clinical trials.
Eylea 8 mg has been approved to date in more than 60 markets for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME).
Eylea 8 mg is an anti-vascular endothelial growth factor-treatment (anti-VEGF) that is approved for extended treatment intervals of up to 6 months both in nAMD and DME in the EU and UK.
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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