- 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 Bayer AG ( OTCPK:BAYZF ) ( OTCPK:BAYRY ) 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 .
For further details see:
Regeneron's high-dose Eylea application accepted for FDA priority review