FDA Issues Complete Response Letter for Regeneron's 8 mg Aflibercept Formulation Due to Third-Party Filler Issues

On June 27, Regeneron announced that it had received a Complete Response Letter (CRL) from the FDA regarding the marketing application for the 8mg formulation of aflibercept. In the CRL, the FDA stated that the refusal to approve was due to issues with a third-party filler, and was unrelated to efficacy, safety, trial design, labeling, or active pharmaceutical ingredient manufacturing.

Regeneron stated that it will closely collaborate with the FDA and a third-party filler supplier to ensure the rapid market launch of the 8mg formulation of aflibercept. Regeneron did not disclose specific information about this third-party filler supplier.

Affected by this news, Regeneron's stock price fell by 8.7%.

Aflibercept is a VEGFR-Fc fusion protein jointly developed by Bayer and Regeneron. It was first approved for marketing in the United States in November 2011 under the trade name Eylea (Aflibercept 2mg). Regeneron holds the exclusive rights to Aflibercept in the United States, while Bayer has exclusive marketing rights outside the United States. Eylea is injected once every two months. The Aflibercept 8mg formulation, a long-acting preparation introduced by Regeneron and Bayer to extend the dosing interval, can reduce the injection frequency to once every four months.

According to Regeneron's financial report, Eylea achieved sales of $9.647 billion in 2022, a year-on-year increase of 4%, including $6.265 billion in revenue from the U.S. and $3.383 billion from markets outside the U.S. (marketed by Bayer, with Regeneron receiving $1.3 billion).

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