Regeneron’s Eylea Stumbles as FDA Issues CRL for New Dosing Label

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Tarrytown, N.Y.-based Regeneron received some unwelcome news. The U.S. Food and Drug Administration (FDA) rejected the company’s attempt to secure a supplemental approval for its blockbuster drug Eylea as a once-per 12-week treatment for wet age-related macular degeneration (wet AMD).

This morning, Regeneron announced it had received a Complete Response Letter from the FDA regarding its supplemental Biologics License Application for Eylea (aflibercept), a vascular endothelial growth factor (VEGF) inhibitor. Regeneron said the FDA rejected the sBLA over “ongoing labeling discussions.” What those labeling discussions may be, Regeneron has not yet disclosed. Whatever those discussions may be, Regeneron said it anticipates completing the discussions and receiving a final FDA action within the next two months.

Company shares are down slightly this morning as investors react to the FDA decision. Regeneron’s Eylea brings in about $5 billion annually for the company and remains its key lynchpin for revenue. Eylea has been approved as a treatment for wet AMD, macular edema following retinal vein occlusion and diabetic macular edema.  

In wet AMD, abnormal blood vessels leak fluid into the eye, ultimately causing damage and blindness. Affecting more than 20 million people globally, wet AMD is the leading cause of severe vision loss and legal blindness in people over the age of 65.

Eylea is currently approved as a monthly injection for the first three months of use, then once every two months after that. The company was hoping the new dosing would allow for patients to receive the treatment once every three months. Regeneron said the sBLA was based on second-year data from the VIEW studies of patients who were treated with a modified 12-week dosing schedule.

Regeneron’s stumble could be Novartis’ gain. The Swiss pharma company is eying a 2019 launch for RTH258 (brolucizumab), an ophthalmology drug for the treatment of neo-vascular (wet) age-related macular degeneration. Novartis’ RTH258 has not yet been approved by the FDA, but has been shown to be superior against Elyea in wet AMD. During a presentation at the American Academy of Ophthalmology last year RTH258 showed superiority versus Regenerons aflibercept (Eylea) in key secondary endpoints reflective of disease activity in patients with nAMD. Brolucizumab (RTH258) is a humanized single-chain antibody fragment (scFv) designed to inhibit vascular endothelial growth factor (VEGF). Patients treated with RTH258 showed fewer signs of specific disease activity than patients treated with Eylea. Additionally, Novartis said patients who received RTH258 showed less fluid in the deepest part of the retina and superior reductions in retinal thickness, which suggests the potential for a long-lasting effect and decreased treatment need. Novartis’ RTH258 also showed another advantage to Eylea -- less frequent dosing. Data earlier this year hit the same 12-week time frame Regeneron was shooting for with Eylea.

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