Bayer/Regeneron's Aflibercept 8mg Submitted for Approval in China, Offering Dosing Interval of Every Four Months

On December 15, the CDE website showed that Bayer's application for the market approval of Aflibercept Intravitreal Injection Solution had been accepted. It is speculated that the version applied for marketing this time is the high-dose 8mg version of Aflibercept.

Aflibercept is a VEGFR-Fc fusion protein jointly developed by Bayer and Regeneron. Regeneron retains exclusive rights to aflibercept in the United States, while Bayer has obtained exclusive marketing rights outside the United States.

In August this year, Aflibercept 8mg was approved by the FDA for marketing to treat wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and patients with diabetic retinopathy.

The FDA approval was based on the positive data from the Phase III PULSAR study of aflibercept 8mg for the treatment of wAMD and the Phase II/III PHOTON study for the treatment of DME.

At week 48, both studies met the primary endpoint of non-inferiority, showing that aflibercept 8mg administered every 12 or 16 weeks was non-inferior to aflibercept 2mg administered every 8 weeks in improving Best Corrected Visual Acuity (BCVA) scores. The majority of patients were able to maintain the 12- or 16-week injection interval. The success of these two pivotal studies means that the aflibercept 8mg formulation can extend the treatment interval from every 2 months to every 4 months.

In these two studies, the safety of aflibercept 8mg was similar to that of aflibercept 2mg, and no patients experienced adverse reactions such as retinal vasculitis, occlusive retinitis, or endophthalmitis.

According to Regeneron's financial report, the sales of Eylea (Aflibercept 2mg) reached $9.647 billion in 2022, increasing by 4% year-on-year. Sales in the United States were $6.265 billion (exclusively sold by Regeneron), and sales in markets outside the United States were $3.383 billion (handled by Bayer, of which Regeneron received $1.3 billion).

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