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

Jan 18, 2024

Bayer announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) granted market authorisation (MA) for Eylea® 8 mg (aflibercept) to treat neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular oedema (DMO).  The approval was based on studies comparing Eylea® 8mg dosed at 12 or 16 week intervals compared to Eylea® 2mg dosed at 8 week intervals, following initial monthly doses.  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 is the licensee of exclusive marketing rights outside the US.

On 8 January 2024, Bayer received MA from the European Commission for Eylea® 8mg for the same indications as Japan.  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.