Regeneron was seeking approval for the drug to treat wet AMD, the leading cause of blindness among the elderly, and two eye diseases that are common in people with diabetes.Īnalysts were expecting that some doctors could prefer higher-dose Eylea over a lower-dose version of the same drug or Roche's Vabysmo, as it would have a longer gap between injections in the eye.Įylea is normally given in doses of 2 milligrams every eight weeks. Truist analyst Robyn Karnauskas said the compliance issue would mean a delay by about 6 months.Įylea, which recorded $9.65 billion in global sales last year, has been hit since Roche's rival treatment Vabysmo was approved last year for wet age-related macular degeneration (AMD) and diabetic macular edema. The complete response letter did not identify any issues with the drug's clinical efficacy or safety, trial design, labeling or drug substance manufacturing, and no additional clinical data or study have been requested.Īnalysts expect the drug will eventually be approved. Regeneron said it was working with the FDA and the third-party filler to bring the higher dose to patients as quickly as possible. The letter cited an ongoing review of inspection findings at a third-party filler of the higher dose. Food and Drug Administration issued a complete response letter, indicating the agency has reviewed Regeneron's application and has outstanding questions. Regeneron's shares closed down 8.6% at $715.9.

health regulators said on Tuesday they declined to approve a higher-dose version of Regeneron Pharmaceuticals' drug Eylea for treatment of a disease that is the leading cause of blindness among the elderly, and the company's shares fell on the setback to its effort to defend the blockbuster treatment against a fast-gaining rival.

I doser premium pc all doses