Pharmaceutical giant AstraZeneca (AZN) has received marketing authorization from the EU for its Covid-19 prevention drug Evusheld, previously known as AZD7442.
It can be used across a broad population of adults and adolescents aged 12 or older, weighing more than 40 kilos.
Importantly, AstraZeneca said the drug, which is composed of a long-acting antibody combination, retains neutralizing activity against the dominant Omicron subvariant BA.2. The shares gained 0.7% to £99.10.
STRONG EFFICACY
Authorisation was based on results from a clinical development programme which showed a 77% reduction in the risk of developing Covid-19 compared with patients not taking the drug.
The drug provides protection for at least six months with data analysis showing an increased 83% protection over this time frame.
Executive vice president at AstraZeneca Mene Pangalos commented: ‘Evusheld has the potential to provide long-lasting protection against Covid-19 for a broad population of individuals, including those who aren’t adequately protected by a Covid-19 vaccine, as well as those at increased risk of exposure.’
GOING GLOBAL
AstraZeneca said Evusheld is the only long-acting antibody combination with positive phase three data (late stage clinical trials) in the prevention and treatment of Covid-19.
The company is moving ahead with further regulatory filings across the globe for potential emergency use or marketing approvals for Evusheld in both prevention and treatment of Covid-19.
The drug is already approved for emergency use in the US and has been granted conditional marketing authorisation by the MHRA (Medicines and Healthcare products Regulatory Agency) in the UK.
Several European countries also have agreements in place to provide Evusheld.
The treatment is particularly beneficial for the population of people who have a compromised immune system and those receiving other medical treatments and therefore have not been vaccinated.
AstraZeneca said there are around three million people in the EU who fit into this category, In addition, people at increased risk of getting Covid-19 may also benefit from the protection Evusheld provides.
The company reported Evusheld product sales of $85 million in 2021.
