Recently, Regeneron Pharmaceuticals Inc. (REGN) submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) seeking approval to market its VEGF (vascular endothelial growth factor) trap-eye treatment.
Regeneron is seeking clearance from the US regulatory body to market the drug for treating patients suffering from age-related macular degeneration (wet AMD).
The condition results from the growth of new blood vessels beneath the retina which leak blood and fluid. The leakage causes the retina to function improperly thereby resulting in distortion and/or blind spots in central vision. The disorder is the leading cause of blindness in patients aged over 65 in the US and Europe.
While submitting the application, Regeneron requested the US agency to review it on a priority basis. The approval of this request would imply a six month review timeline as opposed to the normal ten month review period.
The BLA is based on positive results from the VIEW program (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD) which consisted of two studies, VIEW 1 and VIEW 2. The studies evaluated the efficacy of VEGF trap-eye versus Roche (RHHBY)/Novartis’ (NVS) Lucentis (ranibizumab), an anti-angiogenic agent approved for treating wet AMD. Regeneron’s eye treatment was found to be as effective as Lucentis.
Both the North American (VIEW 1; n=1217) and the international (VIEW 2; n=1240) studies evaluated VEGF trap-eye for the maintenance and improvement of vision at 0.5mg monthly, 2mg monthly or 2mg every two months (following three loading doses), as against Lucentis injected at 0.5mg every month during the first year of the studies.
Application, seeking approval of the eye treatment in Europe, is expected to be filed in the first half of the year by partner Bayer (BAYRY). The approval of the candidate would not only bolster Regeneron’s top line but would provide additional options for patients suffering from the eye-disease which currently has only one FDA approved therapy.
Our Recommendation
Currently, we have a Neutral stance on Regeneron in the long run, which is supported by the Zacks #3 Rank (short-term Hold recommendation) carried by the company.
BAYER A G -ADR (BAYRY): Free Stock Analysis Report
NOVARTIS AG-ADR (NVS): Free Stock Analysis Report
REGENERON PHARM (REGN): Free Stock Analysis Report
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