- The AstraZeneca treatment is one of many in a family of treatments known as monoclonal antibodies, which infuse patients’ bodies with lab-manufactured disease-combating proteins.
- Antibody treatments have gained increasing attention in recent months in the United States as a viable, though costly, strategy against Covid-19, especially among those who have refused vaccinations.
AstraZeneca Seeks Emergency FDA Approval For New Covid-19 Antibody Treatment
AstraZeneca has requested an emergency approval from the Food and Drug Administration (FDA) for a long-acting antibody treatment to prevent Covid-19 infections in patients at high risk of infection. If approved, the company claimed, it would be the first such preventative treatment available in the United States.
According to the company, the treatment reduced the risk of symptomatic Covid-19 infections by 77% in a trial in which the majority of patients either had underlying medical conditions that increased their risk of severe disease or were not producing enough antibodies after vaccination.
It stated that the treatment may be used with vaccines in individuals with weakened immune systems. Other antibody treatments now available in the United States, including one created by the pharmaceutical company Regeneron, are primarily used to treat people who have already been infected with the Covid-19. According to AstraZeneca, the treatment is intended to last much longer in the body than currently available antibody treatments for Covid-19.
Mene Pangalos, an Executive Vice President at AstraZeneca, said in a statement that “vulnerable populations such as the immunocompromised often aren’t able to mount a protective response following vaccination and continue to be at risk of developing Covid-19. With this first global regulatory filing, we are one step closer to providing an additional option to help protect against Covid-19 alongside vaccines.”
An FDA approval would increase AstraZeneca’s profits, since the company’s Covid-19 vaccine, which is used in a number of countries, has not been approved for use in the United States.
Antibody treatments have gained increased attention in recent months in the United States as a viable, though costly, strategy against Covid-19, especially among those who have refused vaccinations. The Biden administration has highlighted the importance of vaccines in preventing the spread of Covid-19, but has encouraged state and local health authorities to expand access to antibody treatment, which the federal government supports at a cost of about $2,100 per dose.
The AstraZeneca treatment is one of many in a family of treatments known as monoclonal antibodies, which infuse patients’ bodies with lab-manufactured disease-combating proteins.
Last month, a World Health Organization panel recommended that Regeneron’s antibody treatment be used in high-risk Covid-19 patients, while urging the company and its partner, Swiss manufacturer Roche, to reduce the cost and expand access to the treatment.