AstraZeneca Seeks F.D.A. Approval for Covid Antibody Treatment

U.S.|AstraZeneca asks the F.D.A. to authorize an antibody attraction to forestall Covid-19.

• Oct. 5, 2021, 8:55 a.m. ET

AstraZeneca said connected Tuesday that it had asked the Food and Drug Administration to assistance exigency authorization for an antibody attraction to forestall Covid-19 successful radical who are astatine precocious hazard of the disease. If authorized, it would go the archetypal specified preventive attraction to beryllium disposable successful the United States, the institution said.

The institution said successful a connection that the attraction had reduced the hazard of symptomatic Covid-19 by 77 percent successful a proceedings successful which astir participants either had different aesculapian conditions that placed them astatine greater hazard of terrible unwellness oregon were not producing capable antibodies aft vaccination.

It said the attraction could beryllium utilized successful conjunction with vaccines successful radical with weaker immune systems. Other antibody treatments successful usage successful the United States, including 1 developed by the cause shaper Regeneron, person chiefly been utilized to dainty radical who are already infected with the coronavirus.

“Vulnerable populations specified arsenic the immunocompromised often aren’t capable to equine a protective effect pursuing vaccination and proceed to beryllium astatine hazard of processing Covid-19,” Mene Pangalos, an enforcement vice president astatine AstraZeneca, said successful a statement. “With this archetypal planetary regulatory filing, we are 1 measurement person to providing an further enactment to assistance support against Covid-19 alongside vaccines.”

An F.D.A. authorization would rise the fortunes of AstraZeneca, whose coronavirus vaccine, which is successful usage successful galore countries, has not been authorized successful the United States.

Antibody treatments person gained greater attraction successful caller months arsenic an alternative, if expensive, instrumentality against Covid-19 successful the United States, peculiarly by immoderate who person shunned vaccines. The Biden medication has emphasized that vaccinations are the champion mode to forestall the dispersed of the coronavirus, but has urged authorities and section wellness officials to marque antibody therapy — which the national authorities covers astatine a per-dose outgo of astir $2,100 — much wide available.

The AstraZeneca attraction is 1 of respective successful a people of therapies known arsenic monoclonal antibodies, which present lab-made, disease-fighting cells into the bodies of patients, usually done an infusion.

Last month, a World Health Organization sheet endorsed the usage of Regeneron’s antibody attraction successful high-risk Covid-19 patients, portion the wellness bureau urged the institution and its partner, the Swiss shaper Roche, to little the outgo of the therapy and marque it much wide available.