A view of the Regeneron Prescription drugs headquarters in Tarrytown, New York.
Lev Radin | LightRocket | Getty Photographs
Shares of Regeneron fell almost 9% Tuesday after the U.S. Meals and Drug Administration declined to approve a higher-dose model of the corporate’s blockbuster eye illness remedy.
The corporate was looking for approval for an 8-milligram dose of its injection, Eylea, for sufferers with moist age-related macular degeneration — the main explanation for blindness among the many aged — and two different eye illnesses which can be widespread in individuals with diabetes.
Regeneron mentioned the rejection was “solely resulting from an ongoing evaluate of inspection findings at a third-party filler.”
The corporate didn’t present additional particulars on these findings or establish the third celebration, however mentioned the choice was not associated to the drug’s efficacy, security, trial design, labeling or drug substance manufacturing.
That means the drug might doubtlessly win approval down the street.
However a delay will not assist the corporate battle off threats to its Eylea drug franchise, which is going through competitors from Roche Holdings’ eye drug, Vabysmo. Roche’s remedy was accepted final yr.
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Regeneron inventory fell almost 9% Tuesday after an FDA rejection of a higher-dose model of the corporate’s blockbuster eye remedy.