U.S. 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.
June 27 - U.S. health regulators said on Tuesday they declined to approve a higher-dose version of Regeneron Pharmaceuticals'
Regeneron said it was working with the FDA and the third-party filler to bring the higher dose to patients as quickly as possible. Analysts expect the drug will eventually be approved. Truist analyst Robyn Karnauskas said the compliance issue would mean a delay by about 6 months.rival treatment Vabysmo was approved last year for wet age-related macular degeneration and diabetic macular edema.
Analysts 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.Eylea was as effective
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