A view of the Regeneron Pharmaceuticals headquarters in Tarrytown, New York.
Levi Radin | light rocket | fake images
Actions of they regenerated it fell nearly 9% on Tuesday after the US Food and Drug Administration refused to approve a higher-dose version of the company’s hit eye disease treatment.
The company was seeking approval of an 8-milligram dose of its injection, Eylea, for patients with wet age-related macular degeneration, the leading cause of blindness among the elderly, and two other eye diseases that are common in people with diabetes.
Regeneron said the rejection was “solely due to an ongoing review of inspection findings at a third-party landfill.”
The company did not provide further details on those findings or identify the third party, but said the decision was not related to the drug’s efficacy, safety, trial design, labeling or manufacturing.
That suggests the drug could gain approval in the future.
But a delay won’t help the company combat threats to its Eylea pharmaceutical franchise, which is facing competition from Roche holdings‘Eye drug, Vabysmo. Roche’s treatment was approved last year.
Regeneron shares fell nearly 9% Tuesday after the FDA rejected a higher-dose version of the company’s hit eye treatment.