2021-10-05 14:55:46 AstraZeneca Seeks F.D.A. Approval for Covid Antibody Treatment
AstraZeneca Seeks F.D.A. Approval for Covid Antibody Treatment
AstraZeneca announced on Tuesday that it had requested emergency approval from the Food and Drug Administration for an antibody treatment to prevent Covid-19 in people who are at high risk of the disease. If approved, it would be the first such preventive treatment available in the United States, according to the company.
According to the company, the treatment reduced the risk of symptomatic Covid-19 by 77% in a trial in which most participants either had other medical conditions that put them at higher risk of severe illness or were not producing enough antibodies after vaccination.
The treatment could be used in conjunction with vaccines in people with weakened immune systems, according to the study. Other antibody treatments currently in use in the United States, including one developed by the pharmaceutical company Regeneron, have primarily been used to treat people who are already infected with the coronavirus.
“Vulnerable populations, such as the immunocompromised, are frequently unable to mount a protective response following vaccination and remain at risk of developing Covid-19,” said Mene Pangalos, executive vice president at AstraZeneca, in a statement. “With this first global regulatory filing, we are one step closer to providing a second option to help protect against Covid-19 in addition to vaccines.”
An FDA approval would boost AstraZeneca’s fortunes, as its coronavirus vaccine, which is used in many countries, is not approved in the United States.
Antibody treatments have received increased attention in recent months in the United States as an alternative, albeit costly, tool against Covid-19, particularly among those who have avoided vaccines. The Biden administration has emphasized that vaccinations are the most effective way to prevent the spread of the coronavirus, but it has also urged state and local health officials to make antibody therapy, which the federal government covers at a per-dose cost of about $2,100, more widely available.
The AstraZeneca treatment is one of several in a class of therapies known as monoclonal antibodies, which deliver disease-fighting cells into patients’ bodies via infusion.
Last month, a World Health Organization panel recommended using Regeneron’s antibody treatment in high-risk Covid-19 patients, while urging the company and its partner, Swiss manufacturer Roche, to reduce the cost of the therapy and make it more widely available.