Regeneron Announces FDA Review Acceptance of EYLEA's sBLA for the treatment of Diabetic Retinopathy
Shots:
- The sBLA involves results of P-III PANORAMA trial assessing EYLEA treatment from moderate severe-to-severe non-proliferative diabetic retinopathy (NPDR) without diabetic macular edema (DME)
- The announced PDUFA date for EYLEA by US FDA is 13 May- 2019. PANORAMA six months’ results has been announced in March 2018 with expected one year results in H2’18
- EYLEA IV is currently approved in the US and indicated for the treatment of wet age-related macular degeneration- macular edema following retinal vein occlusion- DME- and DR in patients with DME
/ article | Ref: Regeneron | Image: Market exclusive
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