FDA clears AstraZeneca monoclonal antibody combination

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A nurse fills a syringe with the AstraZeneca Covid-19 vaccine

During the week, the US Food and Drug Administration (FDA) authorized the emergency use of a drug manufactured by the pharmaceutical company AstraZeneca, which prevents the spread of coronavirus, and which combines two monoclonal antibodies into a single drug, called as Evusheld.

In a statement issued by the entity, it explained that the product is only approved for people who are not infected or exposed to the virus, and who have an immune system that does not allow them to be vaccinated or a history of adverse reactions to vaccines.

“The product is only licensed for those individuals who are not currently infected with the SARS-CoV-2 virus and who have not recently been exposed to a person infected with SARS-CoV-2,” the FDA said in the statement.

“The authorization also requires that people have a moderately to severely compromised immune system due to a medical condition or due to taking immunosuppressive medications or treatments and may not generate an adequate immune response to the COVID-19 vaccine or a history of serious adverse reactions to a COVID-19 vaccine and / or component (s) of those vaccines, (and) therefore vaccination with an available COVID-19 vaccine is not recommended, according to the approved schedule or licensed, ”the FDA said.

Evusheld is made up of tixagevimab and cilgavimab, and is specifically indicated for adults and children 12 years of age and older, weighing at least 40 kilograms and having moderate to severe immune systems, due to a medical condition or taking immunosuppressive medications or treatments that cannot provide an adequate immune response to vaccination against Covid-19.

In fact, tixagevimab and cilgavimab are long-acting monoclonal antibodies directed specifically against the spike protein of SARS-CoV-2, designed to block the adhesion and entry of the virus into human cells. Tixagevimab and cilgavimab bind to different, non-overlapping sites on the spike protein of the virus.

It should be noted that these antibodies were initially isolated by researchers at Vanderbilt University Medical Center from recovered COVID-19 patients in early 2020.

“Vaccines have proven to be the best defense available against Covid-19. However, there are certain immunosuppressed individuals who may not have an adequate immune response to the Covid-19 vaccine, or those who have a history of serious adverse reactions to a Covid-19 vaccine and therefore cannot receive one and they need an alternative prevention option, ”Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “Today’s action authorizes the use of the combination of two monoclonal antibodies to reduce the risk of developing covid-19 in these people,” he added.

For his part, Myron Levin, a researcher who worked on the Evusheld clinical trial at the University of Colorado School of Medicine, said that “millions of people in the US and around the world remain at serious risk of contracting COVID -19 because their immune system does not generate a sufficient immune response, even after receiving all the recommended doses of vaccine ”,

“I am excited to offer my patients Evusheld as a new easy-to-administer option that provides long-lasting protection that could help them return to their daily lives,” said the researcher.

Regarding the supply of the drug, an AstraZeneca spokeswoman pointed out that the therapy with Evusheld consists of the supply of two consecutive injections that neutralize all previous variants of SARS-CoV-2, adding the official that the company continues to investigate whether the drug can neutralize the newly emerging omicron variant.

“Of the Omicron binding site substitutions relevant to Evusheld that have been tested to date in preclinical trials, none have been associated with escape from neutralization of Evusheld,” the company states. “The in vitro findings demonstrate that Evusheld neutralizes other recent emerging SARS-CoV-2 viral variants, including Delta and Mu variants,” the spokesperson said.

Of the possible side effects of Evusheld, Aristegui Noticias reported that the drug can trigger hypersensitivity reactions (including anaphylaxis), injection site bleeding, headache, fatigue and cough.

Indicates that serious cardiac adverse events were rare in the trials. However, more participants had serious adverse cardiac events (such as myocardial infarction and heart failure) after receiving Evusheld compared to placebo.

However, the agency clarifies that all of these participants had risk factors for heart disease or a history of cardiovascular disease before participating in the clinical trial. It is not clear whether Evusheld caused these adverse cardiac events.

To conclude, AstraZeneca pointed out that with its drug about seven million citizens of the United States could benefit, including people undergoing chemotherapy processes, and those who take immunosuppressive drugs for conditions such as rheumatoid arthritis. Thus, the US government has announced a purchase agreement with AstraZeneca for up to 700,000 doses of Evushield, which should be available throughout the country in the coming weeks.

“Evusheld, which is expected to be available in a few weeks, has the potential to provide much-needed protection to the 7 million Americans who are immunosuppressed,” the statement read. “Pre-exposure prevention with Evusheld is not a substitute for vaccination in people for whom the COVID-19 vaccine is recommended,” concluded the FDA.

The FDA statement reads:

Today, the US Food and Drug Administration (FDA) reviewed the Emergency Use Authorization (EUA) for bamlanivimab and etesevimab (previously licensed for pediatric patients age 12). years of age and older weighing at least 40 kilograms, or about 88 pounds), to further authorize bamlanivimab and etesivimab administered together for the treatment of mild to moderate COVID-19 in all younger pediatric patients, including newborns , who have a positive COVID-19 test and are at high risk of progression to severe COVID-19, including hospitalization or death. This review also authorizes the co-administration of bamlanivimab and etesevimab for post-exposure prophylaxis for the prevention of COVID-19 in all pediatric patients, including neonates, at high risk of progression to severe COVID-19, including hospitalization. or death.

“Now all patients at high risk for severe COVID-19, including children and newborns, have a choice of treatment and prevention after exposure. Children under one year of age who are exposed to the virus that causes COVID-19 may be at particularly high risk for severe COVID-19 and this authorization addresses the medical needs of this vulnerable population, ”said Patrizia Cavazzoni, MD, director of the Center. of FDA Drug Evaluation and Research. “Although today’s authorization includes post-exposure prevention of COVID-19 in children, this therapeutic option is not a substitute for vaccination. Vaccines continue to be our best tool in the fight against the virus and there is a vaccine against COVID-19 licensed for children 5 years of age and older. “

Monoclonal antibodies are proteins made in the laboratory that mimic the immune system’s ability to fight harmful pathogens, such as viruses. Bamlanivimab and etesevimab are monoclonal antibodies that are specifically directed against the SARS-CoV-2 spike protein, designed to block the virus from binding and entering human cells. Bamlanivimab and etesevimab bind to different but overlapping sites on the spike protein of the virus.

In February, the FDA originally authorized the co-administration of bamlanivimab and etesevimab to treat mild to moderate COVID-19 in adult and pediatric patients (12 years of age or older weighing at least 40 kg) with positive viral test results. direct from SARS-CoV-2, and who are at high risk of progressing to severe COVID-19 and / or hospitalization. In September, the agency authorized its use for post-exposure prevention of COVID-19 in certain adults and pediatric patients (12 years and older weighing at least 40 kg) who are at high risk of progression to severe COVID-19. , including hospitalization or death.

To support today’s action, bamlanivimab and etesevimab, given together, were studied in a clinical trial of 125 pediatric patients (14 adolescent patients received placebo), all with at least one risk factor for severe COVID-19, to assess safety. and pharmacokinetics of treatment in pediatric patients. Patients who weighed less than 40 kg (88 pounds) received doses of bamlanivimab and etesevimab adjusted to their body weight, to achieve exposures comparable to those of adults and adolescents who received the authorized dose. Given the similar course of COVID-19 disease, the authorization of bamlanivimab and etesevimab in younger pediatric patients, including neonates, is supported by safety and efficacy data in adolescents and adults, along with additional pharmacokinetic data and safety of the clinical trial in pediatric patients.

Serious adverse reactions including hypersensitivity, anaphylaxis, and infusion-related reactions have been observed with bamlanivimab with and without co-administration of etesevimab. Possible side effects of bamlanivimab and etesevimab taken together include nausea, dizziness, pruritus (itching), and a rash.

The FDA is working with sponsors of all currently licensed therapies to evaluate activity against any global variant of interest to SARS-CoV-2 and is committed to communicating with the public as we learn more.

According to the EUA, fact sheets that provide important information on the emergency use of bamlanivimab and etesevimab, to be administered together, must be available to healthcare providers and to patients, parents, and caregivers. These fact sheets include dosing instructions, possible side effects, and drug interactions.

The USA was issued to Eli Lilly and Co.

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