US-FDA authorises AstraZeneca’s new COVID-19 antibody treatment

December 10, 2021
US-FDA authorises AstraZeneca’s new COVID-19 antibody treatment

Pharmaceutical giant AstraZeneca’s (AZ) first preventative COVID-19 drug has been approved for use by the US Food & Drug Administration (US-FDA). The drug, now formally named Evushield, is a combination of two monoclonal antibodies that work together to prevent infection in vulnerable and immunocompromised populations. Treatment is delivered by intramuscular injection and offers robust protection from infection for up to six months.

Evushield was trialled as a preventive prophylactic in those at high risk of severe COVID-19, and as a post-exposure treatment in hospitalised COVID-19 patients or those exposed to the virus but have yet to test positive. The treatment was found to be most effective as a preventative tool in these high-risk subjects: at six-month follow-up, a Phase 3 trial found those treated with Evushield were 83% less likely to have developed symptomatic COVID-19 compared to those in the placebo group.

[The FDA authorisation is primarily aimed at vaccinated individuals who are unable to mount effective immune responses to the vaccine and not an alternative to vaccination, or a treatment for COVID-19 in those already testing positive.]

AZ has indicated there could be around seven million people in the US who might benefit from Evushield, including those undergoing chemotherapy and those on immunosuppressive drugs for chronic conditions such as rheumatoid arthritis. The US government has announced a purchase agreement with AZ for up to 700,000 doses of Evushield, and they should be accessible to those across the country within the next few weeks.

“Millions of people in the US and around the world remain at serious risk for COVID-19 because their immune systems do not generate a sufficient immune response, even after receiving all recommended doses of vaccine,” said Myron Levin, a researcher from the University of Colorado School of Medicine. “I am excited to offer my patients Evusheld as an easily-administered new option that provides long-lasting protection that could help them return to their everyday lives.”

Investigations are also underway to test the effectiveness of Evushield against the Omicron variant of the coronavirus – AZ is confident the monoclonal antibody treatment will hold up against this variant and several others.

Category: Features, Pharmaceuticals

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