FDA Responds to Regeneron's EYLEA HD Application for Extended Dosing Intervals

2025-04-19 companies

Tarrytown, Friday, 18 April 2025.
On 18 April 2025, Regeneron announced the FDA’s response to its EYLEA HD supplemental application. While safety and efficacy concerns were cleared, the proposal for extended dosing intervals was rejected.

FDA Decision and Its Implications

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) has announced that the U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) on 17 April 2025 regarding its EYLEA HD® (aflibercept) Injection 8 mg Supplemental Biologics License Application (sBLA) for extended dosing intervals [1][2]. The FDA’s decision did not highlight any safety or efficacy issues within the currently approved indications. However, the agency did not concur with Regeneron’s request to extend the dosing interval beyond the existing 16 weeks, contrary to the company’s proposal of up to 24 weeks [1][3].

Current Approval Status of EYLEA HD

EYLEA HD is approved with dosing intervals from every 8 to 16 weeks for conditions such as wet age-related macular degeneration (wAMD) and diabetic macular edema (DME), and from every 8 to 12 weeks for diabetic retinopathy (DR) following initial monthly doses [1][2]. The drug aims to maintain efficacy comparable to standard EYLEA injections, but with fewer doses. While the CRL presented a hurdle, it affirmed the drug’s safety profile as satisfactory under the approved regimen [2].

Impact on Regeneron’s Strategic Plans

Following the FDA’s response, Regeneron is considering its next steps. The company’s trajectory for EYLEA HD hinges on overcoming this regulatory challenge. Despite this setback, Regeneron maintains optimism due to the treatment’s successful safety and efficacy evaluations in other jurisdictions like the European Union and Japan, where the drug is known as Eylea™ 8 mg [3][4]. The decision to extend dosing intervals is crucial in the broader context, aiming to reduce patient burden and differentiate EYLEA HD in a competitive biopharmaceutical landscape [5].

Looking Forward: Regulatory and Market Considerations

As the company processes the FDA’s decision, it remains an integral part of Regeneron’s broader efforts to address severe ophthalmic conditions. Beyond EYLEA HD, Regeneron and its partners like Bayer AG continue to focus on developing treatments for conditions including geographic atrophy and glaucoma [5][6]. The company’s leadership has expressed its commitment to navigating these regulatory challenges strategically to maximize the therapeutic and commercial potential of EYLEA HD [6].

Sources

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