A view of Regeneron Pharmaceuticals’ headquarters in Tarrytown, New York.
Lev Latin | Light Rocket | Getty Images
shares Regeneron The U.S. Food and Drug Administration fell nearly 9% on Tuesday refuse to approve High-dose versions of the company’s best-selling eye disease treatments.
The company is seeking approval for its 8 mg injectable Eylea to treat patients with wet age-related macular degeneration, the leading cause of blindness in the elderly, as well as two other eye diseases commonly seen in diabetics.
Regeneron said the rejection was “solely due to an ongoing review of the results of third-party filling machine inspections.”
The company did not provide further details about those findings or identify the third party, but said the decision had nothing to do with the drug’s efficacy, safety, trial design, labeling or API manufacturing.
This suggests that the drug has the potential to be approved in the future.
But the delay won’t help the company fend off threats to its Eylea drug franchise, which is facing pressure from Roche Holdings‘Eye drops, Vabysmo. Roche’s treatment was approved last year.
Shares of Regeneron fell nearly 9% on Tuesday after the FDA rejected a high-dose version of the company’s blockbuster ophthalmic drug.