A view of the Regeneron Pharmaceuticals headquarters in Tarrytown, New York.
Lev Radin | LightRocket | Getty Images
Shares of Regeneron fell nearly 9% on Tuesday after the U.S. Food and Drug Administration declined to approve a higher-dose version of the company’s blockbuster eye disease treatment.
The company had sought approval for 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 common in people with diabetes.
Regeneron attributed the rejection to an ongoing review of inspection findings at a third-party filler. The company, however, did not provide further details on the findings or identify the third party. It emphasized that the decision was unrelated to the drug’s efficacy, safety, trial design, labeling, or drug substance manufacturing.
This suggests that the drug may still be approved in the future.
Nevertheless, the delay poses challenges for Regeneron to defend its Eylea drug franchise against competition from Roche Holdings’ eye drug, Vabysmo, which received approval last year.
Regeneron stock fell nearly 9% on Tuesday after the U.S. Food and Drug Administration declined to approve a higher-dose version of the company’s blockbuster eye treatment.
Denial of responsibility! VigourTimes is an automatic aggregator of Global media. In each content, the hyperlink to the primary source is specified. All trademarks belong to their rightful owners, and all materials to their authors. For any complaint, please reach us at – [email protected]. We will take necessary action within 24 hours.
