AstraZeneca said the U.S. government agreed to purchase additional 500,000 doses of its Covid-19 preventive medicine Evusheld (tixagevimab/cilgavimab).

AZ had said that it would initially supply 1 million doses of Evusheld. However, if most of the doses go to the U.S., other countries will have limited access to AZs preventive therapy.

AZ welcomed the U.S. governments plan to buy 500,000 doses of Evusheld on Wednesday.

Evusheld is a combination drug mixing long-acting antibodies, tixagevimab and cilgavimab, derived from B cells donated by convalescent patients after Covid-19 infection.

The antibody treatment was discovered by Vanderbilt University Medical Center and licensed to AZ, which optimized the drug with half-life extension.

The medicine aims to prevent Covid-19 infection in immunocompromised people.

According to AZ, the half-life extension more than triples the durability of its action compared to conventional antibodies. In addition, the company said that the consecutive two doses of tixagevimab 150mg and cilgavimab 150 mg could afford up to 12 months of protection from Covid-19.

On Dec. 8, Evusheld received FDA approval for the pre-exposure prophylaxis of Covid-19 in people who experienced serious adverse reactions of Covid-19 vaccines or those with immune compromise. Earlier, the U.S. government signed a deal with AZ to purchase 700,000 doses of Evusheld.

The U.S. has confirmed the purchase of 1.2 million doses of Evusheld so far, and the additional 500,000 doses will be shipped to the U.S. within the first half of this year.

As the U.S. secured most of the initial supply of Evusheld, other countries will face a limited chance to purchase the preventive therapy.

Our headquarters basic stance is that we will apply for marketing license in countries that confirmed the pre-purchase of Evusheld, an official at AstraZeneca Korea said. As the quantity of Evusheld is insufficient, we are distributing the remaining stock of Evusheld, excluding those going to the U.S., to several developed countries in Europe.

This means that if the Korean government does not discuss a pre-purchase of Evusheld, AZ will not seek marketing approval pre-emptively.

The Ministry of Food and Drug Safety is doing a preliminary review on Covid-19 vaccines and treatments. But this happens only when a company submits related data.

The regulator is not reviewing Evusheld now.

However, the Korea Disease Control and Prevention Agency (KDCA) plans to discuss Evusheld purchase with AZ soon. The drug is expected to become an option for Korean immunocompromised people to prevent Covid-19.

View original post here:
US will buy additional doses of Covid-19 preventive drug Evusheld. What about Korea? - Korea Biomedical Review

Comments are closed.