An Anglo-Swedish pharmaceutical company wants regulatory approval for new medication that could dramatically help COVID-19 patients reduce the risk of developing symptoms.
AstraZeneca is asking the U.S. Food and Drug Administration (FDA) and foreign governments to authorize emergency use for its AZD7442 antibody cocktail. The first protective injection against the virus is touted to have a 77 percent rate of effectiveness, representing a huge step forward in the worldwide fight against the pandemic.
Unlike vaccines that rely on one-body immune systems to produce specific antibodies and infection-fighting cells, Astra’s biotech substance contains “lab-made antibodies” that stay in the body for months to isolate the virus according to Reuters.
Competitors like Regeneron, Eli Lilly, and GlaxoSmithKline, as well as its partner Vir, provide treatments method based on the same class of monoclonal antibodies to prevent the illness from deteriorating during early, milder stages of infection.
AstraZeneca’s product is promised to last several months to a year. It is claimed to protect patients without a robust immune response to COVID-19 vaccines, owing to chemotherapy or anti-rejection medication after organ transplant.
The cocktail is administered in two steps. It can also be used to augment a vaccine course for people who require additional protection like military personnel.
In September, the FDA approved Regeneron’s drug for preventing COVID-19 infection after being exposed.
A June study shows AZD7442 failed in the post-exposure setting. Another experiment is under underway to see if the medication can be used to treat unwell patients. The pharmaceutical giant agreed to supply the United States with up to 500 million extra doses of the antibody mixture. The $205 million extended arrangement builds on an existing U.S. contract to supply of 200,000 pills that was signed one year prior.
The United States provided $23.7 million in early support for the development project in June 2020. The British government has agreed on 1 million doses of AZD7442 in-principle. The administration refuses to offer any further information.
AstraZeneca’s contract manufacturer, Lonza, previously created the antibody therapy in Portsmouth, New Hampshire during in the first half of 2021.