EUA granted to AstraZeneca’s antibody therapy for COVID-19 prevention
pharmafile | December 9, 2021 | News story | Business Services |
AstraZeneca announced that its Evusheld antibody combination for the prevention of COVID-19 in immunocompromised adults and adolescents has been granted Emergency Use Authorisation (EUA) by the FDA. The EUA application was filed by the company in October last year, and a licence to the antibodies discovered by Vanderbilt University Medical Center was attained last year.
Evusheld is a mixture of two long-acting antibodies (LAAB), tixagevimab co-packaged with cilgavimab. It was obtained from the B-cells of convalescent patients following COVID-19 infection. Evusheld can be used in people with moderate to severe immune compromise due to a medical condition, or those on immunosuppressive medications who may not mount an adequate immune response to COVID-19 vaccination. It can also be used in individuals for whom COVID-19 vaccination is not recommended.
“We are proud to play a leading role in fighting the COVID-19 pandemic and, with Evusheld, we now have the first antibody therapy authorised in the US to prevent COVID-19 symptoms before virus exposure, while also providing long lasting protection with a single dose,” said Mene Pangalos, executive vice president of BioPharmaceuticals R&D at AstraZeneca. “Evusheld neutralises all previous SARs-CoV-2 variants to date, and we are working quickly to establish its efficacy against the new Omicron variant.”
Evusheld is to be administered intramuscularly. The initial doses of the therapy are anticipated to be made available in the coming days. Those who are infected with, or who were exposed to, COVID-19, are not permitted to use Evusheld.
The EUA is based on data from the Phase III PROVENT pre-exposure prevention clinical trial of Evusheld. Treatment from Evusheld demonstrated a 77% decline in symptomatic development risk of COVID-19 at initial assessment, and 83% during six-month analysis verses placebo.
Ana Ovey
