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news.The US Food and Drug Administration (FDA) has accepted to priority review the supplemental biologics license application (sBLA) for Regeneron Pharmaceuticals' Eylea (aflibercept) Injection to treat diabetic retinopathy in patients with diabetic macular edema (DME).
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The goal for a priority review is six months, for a target action date of 30 March 2015, as per the Prescription Drug User Fee Act (PDUFA).
In September, the FDA granted Eylea Injection breakthrough therapy status to treat diabetic retinopathy in DME patients.
Regeneron chief scientific officer and Regeneron Laboratories president George Yancopoulos said: "Diabetic retinopathy coupled with DME is a significant threat to vision for people with diabetes.
"Regeneron looks forward to working with the FDA to help address this significant treatment gap in a leading cause of blindness in working-age adults."
The approval of Eylea in DME is based on data from Phase III VIVID-DME and VISTA-DME trials, which included a pre-specified secondary endpoint evaluating diabetic retinopathy based on an established grading scale in patients with DME.
Around 862 patients were included in these trials which compared Eylea 2mg given monthly, Eylea 2mg given every two months (after five initial monthly injections), or macular laser photocoagulation.
For all approved indications, Eylea (aflibercept) Injection is available as a single, 2mg strength intravitreal injection.
In the US, Eylea is approved to treat wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and DME.