- The Food and Drug Administration issued a Complete Response Letter to Regeneron Pharmaceuticals over its pre-filled syringe for the company's eye drug treatment Eylea, the company disclosed Thursday.
- The U.S. regulator asked for more information on manufacturing and supply, along with a completed usability study. Regeneron said it aims to resubmit the Prior-Approval Supplement in early 2019, keeping it in line for a launch sometime next year.
- The company also rolled out Phase 3 results for Eylea in non-proliferative diabetic retinopathy. Eylea injections improved diabetic retinopathy, reduced vision-threatening complications and cut the development of center-involved diabetic macular edema. The Prescription Drug User Fee Act date for Eylea's supplemental application in diabetic retinopathy is May 13, 2019.
Eylea (aflibercept), a vascular endothelial growth factor inhibitor, is already approved for the treatment of wet age-related macular degeneration, macular edema caused by diabetes or retinal vein occlusion and diabetic retinopathy in patients with diabetic macular degeneration.
Regeneron has submitted a supplemental biologics license application for the treatment of diabetic retinopathy, based on the results of the Phase 3 PANORAMA trial, and this will broaden the drug's market across more patients with type 2 diabetes at risk of severe vision loss.
The FDA's rejection on the syringe, which related to manufacturing of the pre-filled syringes, isn't the first that Regeneron has received for Eylea. In August this year, it picked up a Complete Response Letter for the indication of wet AMD, relating to "ongoing labeling discussions", which was resolved within a few days.
As this one required the completion of a study, it is likely to take longer, but the company is still confident of a launch next year. Any delays could be a challenge in Regeneron's battle against Roche's Lucentis (ranibizumab) though. Roche has already secured U.S. approval of pre-filled syringe options for all of Lucentis' current indications, helping its effort to boost market share.
Regeneron's head of commercial, Marion McCourt, noted a pre-filled syringe "will be helpful to physicians" in a second quarter earnings call. McCourt said Eylea has taken about 20 market share points from its competitors as it has grown.
Diabetic retinopathy affects roughly eight million people. While it may start without symptoms, it can progress to proliferative diabetic retinopathy and cause severe sight loss.
Correction: A previous version of this article mischaracterized the status of Roche's development work involving Lucentis pre-filled syringe options, which are already approved.