8th Dec 2021 22:08
(Alliance News) - AstraZeneca PLC said Wednesday its anti-Covid cocktail called Evusheld has been granted emergency use in the US for pre-exposure prophylaxis of Covid.
It is the first authorised for long-term prevention against Covid-19 infection, rather than a short-term treatment.
The move comes after Astra said in October trials showed that the drug, made from a combination of two monoclonal antibodies, reduced severe Covid-19 symptoms and deaths.
"The Food & Drug Administration granted the EUA for Evusheld for pre-exposure prophylaxis of Covid-19 in adults and adolescents, aged 12 and older, with moderate to severe immune compromise due to a medical condition or immunosuppressive medications and who may not mount an adequate immune response to Covid-19 vaccination, as well as those individuals for whom Covid-19 vaccination is not recommended," the blue chip pharma firm explained.
Evusheld, Astra said, is a combination of two long-acting monoclonal antibodies and is the only antibody therapy authorised in the US for Covid-19 pre-exposure prophylaxis and the only Covid-19 antibody delivered as an intramuscular dose.
Mene Pangalos, executive vice president of BioPharmaceuticals R&D at Astra, said: "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.
"Evusheld neutralises all previous SARs-CoV-2 variants to date, and we are working quickly to establish its efficacy against the new Omicron variant. We thank our clinical trial participants, the investigators, scientists, and government agencies and our colleagues at AstraZeneca who have all contributed to the development of Evusheld."
Astra noted the ongoing Provent Phase III trial showed a 77% reduction in the risk of developing symptomatic Covid compared to placebo, and saying the protection from the virus continues for at least six months. Astra stressed more follow-up is needed to establish the full duration of protection provided by Evusheld.
By Paul McGowan; [email protected]
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