Bayer Aflibercept 8 mg recommended for approval in EU
Berlin: Bayer has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending aflibercept 8 mg with extended treatment intervals in two major retinal eye diseases, neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) for approval.
This includes injections with aflibercept 8 mg at extended treatment intervals of up to every 4 months, after 3 initial monthly doses. In patients with stable visual outcomes, treatment intervals of up to 5 months may be considered.
"Once approved, aflibercept 8 mg will be the only approved drug providing extended treatment intervals of up to 5 months, based on results in clinical trials, for patients with nAMD and DME," the release stated.
The CHMP recommendation is based on positive results from the PULSAR clinical trial in nAMD and the PHOTON trial in DME. Both studies met their primary endpoint of non-inferior best corrected visual acuity (BCVA) changes with aflibercept 8 mg with 12- or 16-week dosing regimens compared to Eylea (aflibercept 2 mg) with a fixed 8-week treatment interval at week 48.
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