The U.S. Food and Drug Administration (FDA) on Dec. 8 issued an emergency use authorization for an AstraZeneca COVID-19 antibody drug designed to help prevent infection in people with compromised immune systems.
The drug, called Evusheld, is a combination of two long-acting synthetic antibodies: tixagevimab and cilgavimab, which are derived from B-cells donated by patients who have recovered from the SARS-CoV-2 virus. It is the first antibody therapy authorized in the United States for preventative COVID-19 treatment.
Both of the antibodies work by mimicking the immune system’s ability to fight the virus and are specifically designed to act against the spike protein of SARS-CoV-2, blocking the virus’ attachment and entry into human cells.
Evusheld, formerly known as AZD7442, is only authorized for use in individuals who are not currently infected with SARS-CoV-2 and who have not recently been exposed to an individual infected with the virus.
“Based on the FDA’s review of the totality of the scientific evidence available, the agency has determined that it is reasonable to believe that Evusheld may be effective for use as pre-exposure prevention in certain adults and pediatric individuals,” the agency said in an announcement.
It has been authorized for use specifically in adults and adolescents aged 12 and older who weigh 40 kilograms (about 88 pounds) or more, with moderate to severe immune compromise, either due to a medical condition or immunosuppressive medications.
Such medical conditions and treatments include blood cancer patients, organ transplant recipients, those with advanced or untreated HIV infection, and people taking immunosuppressive drugs for conditions like rheumatoid arthritis, among others.
The treatment can also be administered to individuals for whom COVID-19 vaccinations are not recommended, such as those who have a history of severe adverse reactions to the shots, the FDA said.
Evusheld will be given as two intramuscular injections, one straight after the other, and the treatment may provide up to six months of pre-exposure prevention, as per the FDA.
Preliminary data from trials showed a significant reduction in the risk of developing symptomatic COVID-19 of 77 percent at primary analysis and 83 percent at median six-month analysis compared to those who took a placebo.
Trials are still ongoing but those who received the shot generally tolerated it well. However, side effects include hypersensitivity reactions, bleeding at the injection site, headache, fatigue, and cough.
Serious cardiac adverse events, such as heart failure, while infrequent, were noted but officials said that such reactions occurred in those individuals who had a history of cardiovascular disease or had a risk factor for cardiac disease.
Both the FDA and AstraZeneca warned that the new drug is only for use in those individuals who are immune-compromised or for whom it is not recommended to have the vaccinations. They said the injection drug is not a substitute for vaccination in individuals for whom the currently available COVID-19 shots are recommended.
The FDA said it has determined that the “known and potential benefits of Evusheld, when used consistent with the terms and conditions of the authorization, outweigh the known and potential risks of the product,” noting that there are currently no such “adequate, approved, and available alternatives” on the market.
In a statement, AstraZeneca said the first doses are expected to become available “very soon.” It did not provide a specific date.
The British-Swedish pharmaceutical and biotechnology company noted that roughly 2 percent of the global population is considered at increased risk of an inadequate response to the current COVID-19 vaccines that are available, while around seven million people in the United States are immunocompromised and may benefit from the treatment.
“We are proud to play a leading role in fighting the COVID-19 pandemic and, with Evusheld, we now have the first antibody therapy authorized in the U.S. to prevent COVID-19 symptoms before virus exposure, while also providing long-lasting protection with a single dose,” Mene Pangalos, executive vice president of AstraZeneca’s BioPharmaceuticals R&D, said.
Effectiveness Against Omicron
Pangalos said that the pharmaceuticals company is still looking into if and how the new treatment may help fight against the new Omicron variant of COVID-19.
“Evusheld neutralizes all previous SARs-CoV-2 variants to date, and we are working quickly to establish its efficacy against the new Omicron variant,” he said. “We thank our clinical trial participants, the investigators, scientists, and government agencies and our colleagues at AstraZeneca who have all contributed to the development of Evusheld.”
The pharmaceutical giant has agreed to supply 700,000 doses of Evusheld to the United States.
From The Epoch Times
