View of the Regeneron Pharmaceuticals headquarters in Tarrytown, Recent York.
Lev Radin | LightRocket | Getty Images
Actions regeneron it fell nearly 9% on Tuesday after the U.S. Food and Drug Administration refused to approve the next dose version of the corporate’s hit drug for eye diseases.
The corporate sought approval of an 8-milligram dose of its injection, Eylea, for patients with wet age-related macular degeneration – the leading explanation for blindness within the elderly – and two other eye conditions which might be common in individuals with diabetes.
Regeneron said the rejection was “solely as a result of an ongoing review of inspection results on the external filler.”
The corporate didn’t provide further details about these findings or discover a 3rd party, but said the choice was not related to the drug’s effectiveness, safety, study design, labeling or manufacturing of the drug substance.
This means that the drug could potentially gain approval in the longer term.
However the delay won’t help the corporate fend off threats to its Eylea drug franchise, which faces competition Rocha Holdingeye medicine, Vabysmo. Roche’s treatment was approved last 12 months.
Regeneron shares fell nearly 9% on Tuesday after the FDA rejected a higher-dose version of the corporate’s blockbuster eye treatment.