A view of Regeneron Pharmaceuticals’ headquarters in Tarrytown, New York.
Lev Radin | LightRocket | Getty Images
Shares of Regeneron fell nearly 9% Tuesday following the U.S. Food and Drug Administration refused to approve a higher-dose version of the company’s blockbuster eye disease treatment.
The company sought approval for an 8-milligram dose of its injection, Eylea, for patients with wet age-related macular degeneration — the leading cause of blindness in the elderly — and two other eye diseases common in people with diabetes.
Regeneron said the rejection was “solely due to an ongoing review of inspection findings at a third-party filler.”
The company did not provide further details about those findings or identify the third party, but said the decision had nothing to do with drug efficacy, safety, trial design, labeling or manufacturing.
That suggests the drug could potentially get approval later.
But a delay won’t help the company fend off threats to its Eylea drug franchise, which faces competition from Roche Holdingseye medicine, Vabysmo. Roche’s treatment was approved last year.
Shares of Regeneron fell nearly 9% on Tuesday following an FDA rejection of a higher-dose version of the company’s blockbuster eye treatment.