Regeneron Pharmaceuticals Inc (NASDAQ:REGN) shares plummeted by nearly 9% in after-hours trade on Tuesday after the US Food and Drug Administration (FDA) declined to approve a higher-dose version of the company's eye disease treatment.
The rejected dosage was an 8-milligram injection of Eylea, intended for patients with wet age-related macular degeneration (wAMD), the primary cause of blindness among the elderly, as well as two other common eye diseases associated with diabetes.
In a statement, Regeneron attributed the FDA's decision to an ongoing inspection review of findings at a third-party filler. However, the company refrained from disclosing specific details regarding the findings or revealing the identity of the third party.
Regeneron emphasized that the rejection did not stem from concerns related to the drug's effectiveness, safety, trial design, labeling, or manufacturing of the drug substance, which suggests that the drug may still have a chance for future approval.
In response to the FDA's decision, Regeneron said it is "committed to working closely with the FDA and the third-party filler to bring aflibercept 8 mg to patients with wAMD, DME and DR as quickly as possible."
The setback presents challenges for Regeneron in defending its Eylea drug franchise, which is currently contending with competition from Roche Holdings' eye drug, Vabysmo, which gained FDA approval last year.
Contact the author at jon.hopkins@proactiveinvestors.com