AstraZeneca asks FDA to authorize COVID antibody treatment

LONDON (AP) — AstraZeneca, the drugmaker that developed 1 of the archetypal COVID-19 vaccines, has asked the U.S. Food and Drug Administration to authorize the exigency usage of a first-of-a-kind antibody attraction to forestall the disease.

The Anglo-Swedish institution said Tuesday that the treatment, known arsenic AZD7442, would beryllium the archetypal long-acting antibody operation to person an exigency authorization for COVID-19 prevention. If authorized, the cause would apt beryllium constricted to radical with compromised immune systems who don’t get capable extortion from vaccination.

The FDA has authorized 3 different antibody drugs already, including 2 that tin beryllium fixed aft a imaginable COVID-19 vulnerability to caput disconnected symptoms. AstraZeneca’s cause would alternatively beryllium fixed arsenic a preventive measurement successful radical who person accrued vulnerability to the virus.

The FDA has stressed that antibody drugs are not a substitute for vaccination, which is the astir effective, long-lasting signifier of microorganism protection. Antibody drugs besides are costly to nutrient and necessitate an IV oregon injection and wellness attraction workers to administer.

Late-stage quality trials showed that AstraZeneca’s antibody cause reduced the hazard of processing symptomatic COVID-19 by 77%. More than three-quarters of the participants had suppressed immune systems and different conditions that made them much susceptible to terrible disease.

“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, AstraZeneca’s enforcement vice president for pharmaceutical research, 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.”

The drugs are laboratory-made versions of virus-blocking antibodies that assistance combat disconnected infections. The treatments assistance the diligent by supplying concentrated doses of 1 oregon 2 antibodies.

U.S. request for the treatments soared implicit the summer, peculiarly successful states similar Florida, Louisiana and Texas, wherever unvaccinated patients threatened to overwhelm hospitals.

The main antibody treatments being utilized successful the U.S. are from Regeneron and Eli Lilly & Co. The U.S. authorities has purchased bulk quantities of some drugs and oversees their organisation to the states.

AstraZeneca said it is successful acquisition talks with the U.S. and different governments astir the world.