[ad_1]
A view of Regeneron Pharmaceuticals’ corporate headquarters and R&D on Old Saw Mill River Road in Tarrytown, New York.
Lev Radin | Light Rocket | Getty Images
shares Regeneron It fell nearly 9% on Tuesday after the US Food and Drug Administration Refuse consent A higher-dose version of the company’s popular eye treatment.
The company was seeking approval for an 8-milligram dose of its injection, Eylea, for patients with age-related macular degeneration — the leading cause of blindness among the elderly — and two other eye diseases common in people with diabetes.
Regeneron said the refusal was “only due to the ongoing third-party review of inspection results”.
The company did not provide more details about these findings or identify the third party, but said the decision was not related to the drug’s efficacy, safety, trial design, labeling, or manufacturing of the drug’s materials.
This indicates that the drug may be approved in the future.
But the delay won’t help the company fight threats to its Eylea drug franchise, which faces competition from Eylea. Roche HoldingEye medication, Vabysmo. Roche’s treatment was approved last year.
Regeneron stock fell nearly 9% Tuesday after the FDA refused to release a higher dose of the company’s popular eye treatment.
[ad_2]
