Ineffective Against Current Variants, Evusheld’s FDA Authorization Revoked
The FDA withdrew authorization Thursday for use of AstraZeneca's antibody drug Evusheld to treat covid as new strains have evolved past the therapy's efficacy. If those variants subside, approval could be reconsidered the FDA said.
Bloomberg:
AstraZeneca’s Covid Drug Loses US Authorization Due To Variants
AstraZeneca Plc’s Covid antibody drug is no longer authorized for use in the US, regulators said Thursday, as it’s unlikely to work against strains of the virus that are now dominant across the country. Astra’s drug, called Evusheld, was authorized in December 2021 to prevent Covid infection in high-risk people, but has been rendered less effective by the virus’ mutations. (Muller, 1/26)
CNBC:
FDA Withdraws Covid Antibody Treatment Evusheld Because It’s Not Effective Against 93% Of Subvariants
Evusheld is also not effective against the BQ.1, BQ.1.1 and XBB subvariants. Taken together with XBB.1.5, versions of Covid that are resistant to Evusheld now represent nearly 93% of new cases in the U.S. “Today’s action to limit the use of Evusheld prevents exposing patients to possible side effects of Evusheld such as allergic reactions, which can be potentially serious, at a time when fewer than 10% of circulating variants in the U.S. causing infection are susceptible to the product,” the FDA said in a statement Thursday. (Kimball, 1/26)
Stat:
FDA Pulls Evusheld Authorization As Coronavirus Evolution Quashes Another Therapy
In a statement, AstraZeneca said it has started trials of another antibody that, in lab studies so far, has been able to neutralize all variants. The therapy, which would similarly be given as a pre-exposure prophylaxis to immunocompromised people, could be available later this year if trials are successful, the company said. The company’s statement also noted that Evusheld remains authorized in other countries, including the European Union and Japan. (Joseph, 1/26)
