AstraZeneca PLC
AZN
announced that the European Commission has granted marketing authorization to its long-acting cocktail antibody therapy, Evusheld, for pre-exposure prophylaxis (prevention) of COVID-19 infection in adults and adolescents aged 12 years and above and weighing at least 40 kg.
Formerly known as AZD7442, Evusheld is a combo of two monoclonal antibodies, tixagevimab (AZD8895) and cilgavimab (AZD1061).
The approval in the European Union based on data from the PROVENT phase III pre-exposure prophylaxis study, which showed that treatment with Evusheld led to a 77% reduction in the risk of developing symptomatic COVID-19 versus placebo. It also demonstrated an 83% reduction at a six-month median analysis, with protection from the COVID-19 virus lasting for at least six months.
Per the press release, treatment with Evusheld retained neutralizing activity against the Omicron BA.2 subvariant, which is currently the dominant COVID-19 strain in Europe.
Last week, Evusheld was recommended for marketing authorization in the European Union for pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents aged 12 years and above with a weight of at least 40 kg.
Shares of AstraZeneca have rallied 11.8% so far this year compared with the
industry
’s increase of 2.5%.
Image Source: Zacks Investment Research
We remind investors that in December 2021, the FDA granted Emergency Use Authorization (“EUA”) to Evusheld for pre-exposure prophylaxis (prevention) of COVID-19 in some individuals.
The cocktail medicine is authorized for adults and adolescents (aged 12 and older) who are immunocompromised due to either a medical condition or immunosuppressive medications, those who cannot get sufficient immune response from COVID-19 vaccination, as well as for those who cannot get vaccinated. These individuals, however, should not have been exposed to the SARS-CoV-2 virus.
Following the EUA, Evusheld became the first cocktail antibody drug approved in the United States to prevent COVID-19 symptoms before virus exposure.
Earlier this month, Evusheld also received marketing authorization for the prevention of COVID-19 in Great Britain.
Please note that, recently, the FDA revised the EUA granted to
Vir Biotech
VIR
/
GlaxoSmithKline
’s
GSK
monoclonal antibody, sotrovimab, for the treatment of COVID-19 infection.
The FDA’s decision to limit the EUA for Glaxo/Vir Biotechnology’s antibody therapy is based on new data, which showed that the treatment option was not effective against the Omicron BA.2 subvariant.
In January 2022, both Lilly and
Regeneron
REGN
faced a similar setback for their respective antibody cocktails for COVID-19 treatment.
The FDA
revised
the EUA granted to the antibody cocktails developed by Lilly and Regeneron based on data showing that the treatments are unlikely to be effective against the Omicron variant.
Zacks Rank
AstraZeneca currently carries a Zacks Rank of #3 (Hold). You can see
the complete list of today’s Zacks #1 Rank stocks here
.
7 Best Stocks for the Next 30 Days
Just released: Experts distill 7 elite stocks from the current list of 220 Zacks Rank #1 Strong Buys. They deem these tickers “Most Likely for Early Price Pops.”
Since 1988, the full list has beaten the market more than 2X over with an average gain of +25.4% per year. So be sure to give these hand-picked 7 your immediate attention.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days.
Click to get this free report
