Astrazeneca’s Evusheld Recommended For Marketing Authorization In The European Union

Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination from AstraZeneca, has been recommended for marketing authorization in the European Union (EU) for COVID-19 pre-exposure prophylaxis (prevention) in a broad population of adults and adolescents aged 12 years and older who weigh at least 40 kg.

Pre-exposure prophylaxis with Evusheld may be especially beneficial for people who have not been sufficiently protected by the COVID-19 vaccination. This comprises around three million EU citizens who are immunocompromised or using immunosuppressive medications.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) gave its approval after reviewing Evusheld data, which showed a 75 percent reduction in the risk of developing COVID-19 symptoms as compared to placebo at the primary analysis and an 83 percent reduction at a six-month median analysis, with protection for about 6 months from the virus. In the experiment, Evusheld was usually well-tolerated.

In Europe, the recommended dose of Evusheld is 150 mg tixagevimab and 150 mg cilgavimab, given as two separate intramuscular (IM) injections.

A growing body of evidence from multiple independent in vitro and in vivo (animal model) studies supports Evusheld’s ability to protect against the virus. New data from Washington University School of Medicine showed Evusheld retained potent neutralizing activity against the emerging BA.2 subvariant, which is the dominant strain in many European countries.

In the United States and six European nations, Evusheld is approved for emergency COVID-19 pre-exposure prophylaxis. The Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom has likewise awarded Evusheld conditional marketing authorization for COVID-19 pre-exposure prophylaxis.

AstraZeneca expects the European Commission to finish its evaluation of the CHMP favourable judgement and make a decision on whether or not to award marketing authorization soon.

Evusheld is used in the treatment and prevention of COVID-19 and is the combination of acting antibodies having positive Phase III data. AstraZeneca is moving forward with filings for potential emergency use authorization or marketing nod of Evusheld in both COVID-19 prophylaxis and treatment all over the world.

Despite the efficacy of vaccines, more steps are needed to limit the spread of infection in Europe, where transmissibility is high. BA.2 subvariant is spreading at a pace and public health safety requirements in many countries have been eased. The promptness for choosing Evusheld will allow EU health authorities to identify priority, high-risk individuals that require further protection, such as cancer patients, transplant patients, or anybody using immunosuppressive medications, as well as those who are at higher risk of exposure.

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