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EC Grants MA to Bayer’s Eylea® 8mg (aflibercept) for nAMD and DMO

Jan 8, 2024

Bayer announced that the European Commission (EC) granted marketing authorisation (MA) for Eylea® 8mg (aflibercept) to treat neovascular (wet) age-related macular degeneration (nAMD) and visual impairment due to diabetic macular oedema (DMO).  Eylea® 8 mg is approved for administration at extended treatment intervals of up to every four months, following three initial monthly doses, and in patients with stable visual outcomes intervals of up to five months may be considered.  Eylea® 8 mg is the only treatment in the EU approved for extended treatment intervals of up to five months in nAMD and DMO.

Eylea® 8 mg is jointly developed by Bayer and Regeneron.  Regeneron maintains exclusive rights to Eylea® (aflibercept 2 mg) and Eylea® HD (8mg) in the US.  Bayer has licensed the exclusive marketing rights outside the US.

On 18 August 2023, the FDA approved Eylea® 8mg under the brand name Eylea® HD for the above indications, as well as for diabetic retinopathy.  The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of the 8mg Eylea® for the treatment of nAMD and DMO in November 2023, however Eylea® is not approved for diabetic retinopathy in the EU.