Regeneron's high-dose Eylea application accepted for FDA priority review
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The US FDA has accepted for priority review Regeneron Pharamceuticals' (NASDAQ:REGN) a high-dose version -- 8 mg -- of its best-selling macular degeneration and diabetic macular edema (DME) treatment Eylea (aflibercept).
The company, which markets the drug with BayerÂ AG (OTCPK:BAYZF) (OTCPK:BAYRY)Â used a priority review voucher in the process. The action date is June 27.
The application is supported by data from two trials, PULSAR in wet age-related macular degeneration and PHOTON in DME.
In late January, Cowen upgraded Regeneron (REGN) on the potential of high-dose Eylea due to its less frequent dosing.