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December 19, 2013

Regeneron gets FDA acceptance of Eylea injection sBLA for diabetic macular edema indication

The US Food and Drug Administration (FDA) has accepted Regeneron Pharmaceuticals' supplemental biologics licence application (sBLA) for its Eylea (aflibercept) Injection for standard review for treating diabetic macular edema (DME) patients.

DME

The US Food and Drug Administration (FDA) has accepted Regeneron Pharmaceuticals’ supplemental biologics licence application (sBLA) for its Eylea (aflibercept) Injection for standard review for treating diabetic macular edema (DME) patients.

Under the Prescription Drug User Fee Act (PDUFA), the goal for a standard review of an sBLA is ten months from submission, for a target action date of 18 August 2014.

Regeneron chief scientific officer and Regeneron Laboratories president George Yancopoulos said diabetes is a growing public health concern and DME is a leading cause of vision loss in patients with diabetic retinopathy.

"We hope to be able to offer a new treatment option to patients who suffer from diabetic macular edema," Yancopoulos said.

The Eylea sBLA submission is based on the positive results secured from the Phase III VIVID and VISTA trials.

In the US, the drug was approved for treatment of neovascular (wet) age-related macular degeneration (AMD) in November 2011, and for macular edema following Central Retinal Vein Occlusion (CRVO) in September 2012.

The drug has already been approved in the EU, Japan, Australia, and many other countries for use in wet AMD, as well as in selected countries in Asia and Latin America for the treatment of macular edema following central retinal vein occlusion (CRVO).

"We hope to be able to offer a new treatment option to patients who suffer from diabetic macular edema."

The company said that regulatory submissions have also been made in the EU for Eylea in DME.

Bayer HealthCare and Regeneron are collaborating on the global development of Eylea, with Regeneron maintaining exclusive rights of the drug in the US and Bayer having exclusive marketing rights outside the US, where the companies equally share the profits from its sales, except for Japan where Regeneron receives a royalty on net sales.

The Phase III DME programme consists of three double-masked trials, VIVID-DME, VISTA-DME, and VIVID-EAST-DME (in Russia, China and other Asian countries), and one open-label, single arm safety trial in Japanese patients (VIVID-Japan).

All three double-masked studies have three treatment arms, where patients are given either Eylea 2mg monthly, Eylea 2mg every two months (after five initial monthly injections), or the comparator treatment of laser photocoagulation.

Primary endpoint of all three studies is the mean change in best-corrected visual acuity from baseline, as measured on the Early Treatment Diabetic Retinopathy Scale (ETDRS) eye chart, which is used in research to measure visual acuity.

The company said that VIVID-DME, VISTA-DME, and VIVID-EAST-DME studies are currently ongoing.


Image: Diabetic macular edema. Photo: courtesy of GeeJo.

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