Regeneron Faces Setback as FDA Rejects Extended Dosing for Eylea HD

Regeneron Pharmaceuticals has encountered another obstacle in its efforts to compete with Roche's Vabysmo, as the U.S. Food and Drug Administration (FDA) rejected the company's bid to extend the dosing interval for its high-dose formulation of Eylea (Eylea HD).

FDA Rejection and Market Implications

The FDA issued a complete response letter (CRL) to Regeneron, denying the company's proposal to increase the maximum dosing frequency of Eylea HD from every 16 weeks to every 24 weeks. This decision comes as a significant blow to Regeneron's strategy to regain market share in the treatment of eye diseases such as wet age-related macular degeneration (AMD), diabetic macular edema (DME), and diabetic retinopathy (DR).

Regeneron CEO Leonard Schleifer had previously acknowledged the need for "a few more arrows in its quiver" to compete effectively with Roche's Vabysmo. The extended dosing interval was seen as a crucial differentiator for Eylea HD, as Vabysmo can already be administered at intervals of up to 16 weeks.

Eylea HD's Performance and Competitive Landscape

The rejection comes at a challenging time for Regeneron, as Eylea HD has been struggling to gain traction in the market. Sales of the new formulation declined from $392 million to $305 million in the last two quarters of 2024. In contrast, Roche's Vabysmo has seen significant growth, with sales increasing from 2.36 billion Swiss francs ($2.5 billion) in its first full year to 3.86 billion Swiss francs ($4.2 billion) last year.

The competitive landscape is further complicated by the recent launch of Amgen's Eylea biosimilar, Pavblu, which generated $31 million in sales during its first six weeks on the market in Q4 2024.

Regeneron's Response and Future Plans

Regeneron stated that the FDA "did not agree with Regeneron's proposal to add additional extended dosing intervals" but did not specify any safety or efficacy issues. The company is currently evaluating the FDA's decision and plans to determine a path forward.

Despite this setback, Regeneron continues to pursue other avenues for Eylea HD's growth. The FDA recently accepted the company's application for Eylea HD to treat macular edema following retinal vein occlusion (RVO) and to broaden the dosing schedule to every four weeks across all approved indications.

As the pharmaceutical industry awaits further updates from Regeneron, the company's ability to navigate these challenges and maintain its position in the competitive eye disease treatment market remains to be seen.