June 29, 2022

The anglo-Swedish drug-making company, AstraZeneca’s has announced its antibody cocktail against COVID-19 to have received its provisional registration in Australia.

Australia’s medical regulatory body, the Therapeutic Goods Administration on Tuesday commented that it granted the first provisional determination to the company last week for its antibody cocktail, EVUSHELD. It is the first protective shot other than vaccines against COVID-19.

The regulator mentioned that the provisional determination is the first step in the process to complete registration. It now expects the pharmaceutical to submit an application for provisional registration shortly.

The determination of the antibody-based therapy is already under real-time review in Europe and pending emergency approval in the United States. While the decision by the Australian regulator comes as the country boosts its vaccination rates, recently launching booster shots, amid easing curbs.

About EVUSHELD

AstraZeneca’s cocktail has proven to work as a preventative shot in people not infected with COVID-19. It has also been found to save lives and prevent severe disease when given as treatment within a week of COVID-19’s first symptoms.

The drug is a combination of two antibodies called AZD7442. It has been found to reduce the risk of severe COVID-19 or death by 50% in non-hospitalized patients who have had symptoms for seven days or less.
The company had conducted the trial for the cocktail across 13 countries and involved more than 900 adult participants. Among them, 90% suffered from conditions that made them particularly vulnerable to COVID-19, such as cancer and diabetes.

One-half received the cocktail and the rest a placebo.

Several other pharmaceutical companies around the world are developing similar therapies made with a class of drugs called monoclonal antibodies. Such companies being – Regeneron, Eli Lilly, and GlaxoSmithKline with partner Vir.

These therapies are currently approved for emergency use in the United States for treating mild-to-moderate COVID-19.

According to reports, Regeneron’s therapy showed 72% protection against symptomatic infection in the first week, and 93% after that.

GSK-Vir’s therapy has shown a 79% reduction in the risk of hospitalization or death due to any cause, while Eli Lilly’s has shown a 70% reduction in viral load at day seven when compared to a placebo.