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.
“The clinical trials with aflibercept 8 mg have demonstrated sustained vision gains with extended treatment intervals, rapid and resilient fluid control, and a comparable safety profile to Eylea 2 mg. This concept of sustained disease control has been eagerly anticipated, because greater and longer lasting control of disease activity is needed to alleviate disease burden for patients and capacity constraints at eye clinics and ophthalmologists’ offices,” said Prof. Paolo Lanzetta, Chairman of the Department of Ophthalmology at the University of Udine, Italy, and a member of the steering committee of the clinical trials. “This can contribute to improved patient adherence and persistence, and support physicians to free up resources to help more patients.”
“Eylea has already transformed the standard of care for millions of people in the EU living with neovascular age-related macular degeneration and diabetic macular edema. This positive CHMP opinion underscores the potential of aflibercept 8 mg to set a new benchmark for the treatment of these progressive blinding diseases,” said Dr. Christian Rommel, Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of Research and Development.
The final decision from the European Commission is expected in the coming months. Bayer has applied for the brand name of aflibercept 8 mg to be ‘Eylea 114.3 mg/ml solution for injection’ (Eylea 8mg).
Aflibercept 8 mg was approved for use by the FDA on August 18, 2023. Bayer has submitted regulatory applications for aflibercept 8 mg in additional key markets.
Aflibercept 8 mg is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to Eylea (aflibercept 2 mg) and aflibercept 8 mg 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 (aflibercept 2 mg).
Read also: Bayer expands global life science incubator network
