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FDA Breakthrough Therapy Designation #59: Genentech And Diabetic Retinopathy

December 17, 2014

Genentech, receives this week the FDA Breakthrough Therapy (BTD) for Lucentis (Ranibizumab Injection) for diabetic retinopathy. Lucentis, given by injection into the eye, has FDA approval for the following indications :

•    Diabetic Macular Edema (DME)

•    Neovascular (wet) Age-Related Macular Degeneration (AMD)

•    Macular edema following Retinal Vein Occlusion (RVO).

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 vision problems. There is currently no FDA approved treatment for diabetic retinopathy.

According to an online EyeWireToday article, for Genentech’s Lucentis the FDA :

•    In September 2014, accepts a supplemental Biologics License Application (sBLA) & grants Priority Review for diabetic retinopathy

•    Confirmed action date for the BLA is 02/06/14.

In September 2014, Regeneron Pharmaceuticals receives the FDA BTD for Eylea (Afibercept) injection for the same indication. 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).

Earlier in December, Regeneron Pharmaceuticals announces that the FDA accepts for Priority Review the sBLA for Eylea, for diabetic retinopathy in patients with DME, with a target action date of March 30, 2015.

The watch is on to see which FDA BTD medicine for diabetic retinopathy is approved first, which will be the first to market, how will both medicines compete in the market (i.e. price), and how will each distinguish itself from the other.



FDA BTD Approval Chart

FDA BTD Statistics Chart.

Please Note: “Flickr – Nicholas T – Bows” by Nicholas A. Tonelli from Pennsylvania, USA (Bows) [CC-BY-2.0] | Wikimedia Commons.

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