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FDA Breakthrough Therapy Designation: Regeneron Pharmaceuticals And Diabetic Retinopathy

September 16, 2014

On September 16th, Regeneron Pharmaceuticals, a biopharmaceutical company based in Tarrytown, New York, announces that Eylea (Afibercept) injection receives the coveted FDA Breakthrough Therapy Designation (BTD). The BTD is for Eylea for the treatment of Diabetic Retinopathy in patients with Diabetic Macular Edema (DME). The BTD is based on positive data in two Phase III trials (VIVID-DME and VISTA-DME), where there is a “statistically significant improvement in a pre-specified measure of diabetic retinopathy in patients with DME after 2 years.” Regeneron Pharmaceuticals plans on submitting a sBLA (supplemental Biologics License Application) for this indication by the end of 2014. There is currently no FDA approved treatment for diabetic retinopathy.

Eylea is currently approved in the U.S., European Union (EU), and other countries for the treatment of wet Age-Related Macular Degeneration (AMD), macular edema following Central Retinal Vein Occulsion (CRVO), and DME. In the U.S. and the EU, regulatory submissions have been made for macular edema following Branch Retinal Vein Occulsion (BRVO).

Diabetic retinopathy is a complication of diabetes that results in damaging the eye’s retina, that can lead to poor vision, vision loss, and other vsion problems, such as :

“ … DME, which refers to the swelling of the macula (the part of the retina responsible for central, fine vision) and progression to proliferative diabetic retinopathy, which often results in profound visual loss due to associated complications … DME is the most frequent cause of vision loss in patients with diabetes … ”.

According to an online article, Regeneron Pharmaceuticals reports Eylea net sales for the 1st half of 2014, in the U.S., of $773.8 million compared to $643.7 million for the 1st half of 2013 – approximately 20 % increase.

References

FDA BTD Chart

FDA BTD Approval Chart

FDA BTD Statistics Chart.

Please Note: “Icon Announcer” by Orion 8 [Public domain] | Wikimedia Commons.

Copyright © 2012-2014, Orphan Druganaut Blog. All rights reserved.

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