US FDA vetoes Regeneron’s Eylea syringe in CRL

By Flora Southey

- Last updated on GMT

(Image: Getty/EujarimPhotography)
(Image: Getty/EujarimPhotography)

Related tags Fda Crl Regeneron

The US FDA has rejected Regeneron Pharmaceuticals’ prior-approval supplement for Elyea pre-filled syringe, requesting additional clinical data and manufacturing information.

Eylea (afibercept) pre-filled syringe injection is a vascular endothelial growth factor inhibitor. The product was created to prevent the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels in the eye by blocking two growth factors involved in angiogenesis.

According to Regeneron, the US Food and Drug Administration (FDA) was unable to approve the chemistry, manufacturing and controls (CMC) prior-approval supplement (PAS) in its current state.

“The complete response letter (CRL) requested additional information regarding manufacturing and supply processes and the completion of a usability study evaluating a single injection of the Eylea pre-filled syringe in approximately 30 patients,” ​a company spokesperson told us.

The firm plans to compile all requested information for resubmittal early next year. “We continue to expect a 2019 launch of the Eylea pre-filled syringe,” ​the spokesperson added.

In the same regulatory update​, Regeneron announced its Phase III Panorama trial, which is evaluating Eylea injection in patients with moderately severe and severe non-proliferative diabetic retinopathy, met its one-year primary endpoint and key secondary endpoints.

Regulatory hurdles

The CRL marks Regeneron’s second for the year, after the FDA rejected​ the company’s supplemental biologics license application for Eylea (afibercept) injection, with a 12-week dosing schedule, in August.

The FDA went on to approve the application​ just four days later, having finalised “ongoing labelling discussions” ​with Regeneron. Eylea is also approved for four- or eight-week dosing intervals, after three initial monthly doses.

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