Regulatory AstraZeneca COVID drug gets approval from European regulators

AstraZeneca COVID drug gets approval from European regulators


Earlier this year, Evusheld was given formal authorization from the European Union to prevent the spread of COVID-19 and be administered to a large set of the population consisting of teenagers and adults. The drug is already available in almost all of the nations in Europe.

The company stated, “The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended conditional marketing authorization (CMA) for AstraZeneca’s (AZ) Evusheld (tixagevimab and cilgavimab) for the treatment of people with COVID-19”.

The CHMP’s advice is based on phase 3 findings of a clinical trial. In the study, the participants included patients who were non-hospitalized with mild-to-moderate COVID-19 symptoms for seven days or less, with 90% of the participants being at greater risk of progressing towards severe COVID-19 due to high age factors and multiple diseases. The results showed that one intramuscular injection of Evusheld provides “medically and significantly meaningful” protection against the contraction of severe COVID-19 or death from any cause compared to placebo.

The guideline is specifically for treating adults and adolescents with COVID-19 who do not need supplemental oxygen and are at a higher risk of developing severe illness. These patients must be at least 12 years old and weigh 88lbs or more. Evusheld is a combination of two sets of antibodies derived from B-cells, given by people who had previously been infected by COVID-19.

According to the company, Evusheld had positive results in the experiment compared to placebo. The dosage of tixagevimab and cilgavimab for the treatment of Evusheld in the EU is 300 mg each and it is given in the form of two separate intramuscular injections.

Japan has booked an order of 300,000 doses of evusheld while the U.S. is still debating whether to use Evusheld as a post-infection alternative while comparing its efficacy to that of omicron and its subvariants. Evusheld has been licensed as a COVID prophylactic in the majority of nations throughout the world, giving immunocompromised individuals who are unable to receive appropriate protection from vaccines a valuable alternative. If the need arises, the United States has committed to buying 1.7 million courses of the cocktail for $855 million.

Evusheld sales in the first quarter were $469 million, while in the second quarter an additional $469 million were brought in. Sales in Europe, which totaled $143 million in the first half, should increase if the recommendation results in an authorization.

According to the latest data gathered, when compared to other control groups, Evisheld had a low death/ hospitalisation ratio and a low chance of symptomatic COVID. The corporation stated that this includes evidence gathered while Omicron BA.5, BA.4, BA.2, BA.1, and BA.1.1 were found to be infecting the population. AZ took a step further with the long-acting antibody cocktail and successfully received a favourable recommendation for treatment in patients who are infected and at risk of developing a severe version of the virus from Europe’s Committee for Medicinal Products for Human Use. The World Health Organization (WHO) has prohibited using sotrovimab from GSK as they are not effective in the omicron strain.

Iskra Reic, EVP, vaccines, and immunological treatments, AZ stated “Evusheld has already made a big difference around the world in helping prevent COVID-19 infections in vulnerable groups who can’t mount an appropriate response to COVID-19 immunisation”.

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