And then there were none.
Even though AstraZeneca’s Evusheld held out longer than most, the drug has finally met the fate of so many other COVID-19 antibodies.
This week, the FDA nixed Evusheld’s emergency nod for prevention of COVID-19 until further notice. The regulator noted AZ’s prophylactic has lost effectiveness in the face of circulating SARS-CoV-2 variants.
AstraZeneca is hardly alone. Over the course of the pandemic, FDA has granted—then revoked—emergency nods for antibody drugs from GSK and Vir, Regeneron and Eli Lilly. The revocations were all predicated upon similar variant efficacy concerns.
Still, all hope is not lost, AZ pointed out in a release. The FDA has let the company know it could potentially reinstate Evusheld’s authorization if the nation’s prevalence of resistant variants decreases to 90% or less “on a sustained basis.”
In vitro data has shown Evusheld lost its luster across a range of Omicron subvariants, the FDA said. As it stands, those subvariants combined make up more than 90% of COVID-19 cases in the U.S., AstraZeneca explained.
AstraZeneca’s antibody combo is still approved in other regions—including Europe and Japan—as both a preventive option and COVID-19 treatment.
Further, AstraZeneca is still banking on a potential next-generation successor to Evusheld as a preventive in patients who are immunocompromised.