Coronavirus Pandemic

AstraZeneca asks FDA to authorise Covid antibody treatment

Filed on October 5, 2021
Reuters photo

If authorised, the drug would likely be limited to people with compromised immune systems.

AstraZeneca, the drugmaker that developed one of the first Covid-19 vaccines, has asked the US Food and Drug Administration to authorise the emergency use of a first-of-a-kind antibody treatment to prevent the disease.

The Anglo-Swedish company said on Tuesday that the treatment, known as AZD7442, would be the first long-acting antibody combination to receive an emergency authorisation for Covid-19 prevention. If authorised, the drug would likely be limited to people with compromised immune systems who don’t get sufficient protection from vaccination.

ALSO READ: Australia to buy new oral Covid drug if regulator approves, says PM

Pfizer jab prevents severe Covid for at least 6 months: Study

The FDA has authorized three other antibody drugs already, including two that can be given after a possible Covid-19 exposure to head off symptoms. AstraZeneca’s drug would instead be given as a preventive measure in people who have increased vulnerability to the virus.

The FDA has stressed that antibody drugs are not a substitute for vaccination, which is the most effective, long-lasting form of virus protection. Antibody drugs also are expensive to produce and require an IV or injection and health care workers to administer.

Late-stage human trials showed that AstraZeneca’s antibody drug reduced the risk of developing symptomatic Covid-19 by 77%. More than three-quarters of the participants had suppressed immune systems and other conditions that made them more susceptible to severe disease.

ALSO READ: Covid-19: Australia won’t welcome international tourists until 2022

“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 ,” Mene Pangalos, AstraZeneca’s executive vice president for pharmaceutical research, said in a statement. “With this first global regulatory filing, we are one step closer to providing an additional option to help protect against Covid-19 alongside vaccines.”

The drugs are laboratory-made versions of virus-blocking antibodies that help fight off infections. The treatments help the patient by supplying concentrated doses of one or two antibodies.

U.S. demand for the treatments soared over the summer, particularly in states like Florida, Louisiana and Texas, where unvaccinated patients threatened to overwhelm hospitals.

The main antibody treatments being used in the U.S. are from Regeneron and Eli Lilly & Co. The U.S. government has purchased bulk quantities of both drugs and oversees their distribution to the states.

AstraZeneca said it is in purchase talks with the U.S. and other governments around the world.

ERROR: Macro /ads/dfp-ad-article-new is missing!
MORE FROM Coronavirus Pandemic
MORE FROM Khaleej Times
CurrentRequestUnmodified: /apps/pbcs.dll/article?avis=KT&date=20210830&category=ARTICLE&lopenr=210839897&Ref=AR&_gl=1*875ou5*_ga*T3lTemVzcWNUV19mUjV2Rm5VaGZ4Zm9LeWZxcnExM2V5VEljaGJIOTQxVlphX3NxbTFIUFlUX3FNbEVmN1d6NQ&profile=1913 macro_action: article, macro_profile: ,1913,1000 macro_adspot:
KT App Download
khaleejtimes app

All new KT app
is available
for download:

khaleejtimes - android khaleejtimes - ios khaleejtimes - HUAWEI AppGallery