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The US authorizes a drug against COVID-19 that reduces the chances of hospitalization and death by 85% in people with risk factors

» ProSalud

The FDA, the regulatory agency of that country, authorized sotrovimab for emergency use, while the final stage of the phase 3 clinical trial is completed. It is only for mild and moderate cases. It cannot be used if the patient already needed a respirator.

The drug authorized in the United States is for people with risk factors for developing serious conditions that require hospitalization. Preliminary evidence shows that the drug prevents the progression of the disease by preventing the virus from affecting more healthy cells in the body (EFE/José Jácome/File)

The drug regulatory agency in the United States, better known by its acronym in English as the FDA, authorized for emergency use a new medication to prevent adolescents and adults with risk factors from developing severe symptoms and losing their lives if they become infected with the coronavirus. The medication carries the generic name “sotrovimab” and was authorized only for use in mild and moderate patients who have not yet required hospitalization or are using a respirator.

Days ago, too the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) had issued a positive opinion of sotrovimab after reviewing data from the ongoing Phase 3 clinical trial.

The new treatment is the result of collaborative work between scientific researchers from the pharmaceutical company GSK with Vir Biotechnology, an immunology company that combines its immunological knowledge with cutting-edge technologies to treat and prevent serious infectious diseases. It belongs to the group of monoclonal antibodies, which began to be developed for different diseases based on the pioneering work of the Argentine scientist César Milstein. and the German Georges Köhler in 1975, who later won the Nobel Prize in Medicine.

“This new drug, Sotrovimab is a more specific monoclonal antibody unlike other medications. that were already authorized by the US regulatory agency for the same stage of the disease,” he told Infobae Dr. Isabel Cassetti, medical director of Helios Salud and member of the Argentine Society of Infectious Diseases. The other authorized antibodies are used in combination with others. On the other hand, the new authorized drug targets the Spike protein of the coronavirus: it prevents the virus from entering cells and does not require combination with others. It is indicated in a single dose in outpatients who have risk factors for progression, said the specialist.

The monoclonal antibody sotromibab is indicated only for treatment during the first 10 days of infection after the onset of symptoms and confirmed by a test (EFE/Luis Ángel Gonzales Taipe/File)

The United States regulatory agency authorized sotrovimab for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years and older weighing at least 40 kilograms) with a positive swab and who are at high risk of progression to severe COVID-19, including hospitalization or death.

“The antibody may be indicated in outpatients who, before becoming infected with coronavirus, had hypertension, cardiovascular or respiratory diseases, kidney failure, immunosuppression, oncological diseases, among other risk factors,” commented Dr. Cassetti.

It can be administered during the first ten days of coronavirus infection from the onset of symptoms or the positive PCR result. As is also the case with other monoclonal antibodies, it cannot be indicated when the patient with COVID-19 already required respirator assistance as oxygen therapy. “Sotrovimab is for an initial treatment strategy for COVID-19,” Cassetti said.

According to the United States FDA, sotrovimab therapy is also effective when a person with risk factors becomes infected with one of the coronavirus variants of concern / PAHO

Also, another benefit of the sotrovimab monoclonal antibody is its profile: “It is active against the different variants of concern that have been detected. For this reason, it would be a great contribution for patients with risk factors who acquire coronavirus infection to reduce the risk of hospitalization and death,” said Cassetti.

According to the FDA statement, The safety and effectiveness of sotrovimab therapy continues to be evaluated for the treatment of COVID-19. It was clarified that “it is not authorized for patients who are hospitalized for COVID-19 or who require oxygen therapy.” It has not been shown to be beneficial in hospitalized patients with COVID-19. “Monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients.” that require high-flow oxygen or mechanical ventilation,” the FDA said.

“With the authorization of this monoclonal antibody treatment, we are providing another option to help keep high-risk patients with COVID-19 out of the hospital,” said Dr. Patrizia Cavazzoni, director of the Center for Drug Evaluation and Research at the FDA. “It is important to expand the arsenal of monoclonal antibody therapies that are expected to maintain activity against circulating COVID-19 variants in the United States.”

There are already 12 vaccines authorized in the world. But not the entire population agrees. Meanwhile, there are people who continue to become infected with the coronavirus. The new monoclonal antibody authorized in the US is added to respond to the initial stage of the disease (Reuters/Shannon Stapleton)

Monoclonal antibodies are laboratory-made proteins that mimic the immune system's ability to control harmful antigens such as viruses. In the case of sotrovimab, it is an antibody that was designed to block the adhesion and entry of the virus into human cells.

The regulatory agency considered that when sotrovimab is used to treat only the authorized population (adolescents and adults - including older adults - with previous risk factors), “The known and potential benefits outweigh the known and potential risks of the drug. There are no suitable, approved treatments available as an alternative to sotrovimab.”he warned.

Consulted by InfobaeVentura Simonovich, vice president of the Argentine Association of Experimental Pharmacology and head of Clinical Pharmacology at the Italian Hospital of Buenos Aires, considered: “The development of sotrovimab for patients with risk factors is encouraging, but we need to know more about the clinical trial results when they are published.”

The data supporting the FDA authorization are based on An interim analysis of a randomized, double-blind, placebo-controlled clinical trial in 583 non-hospitalized adults with mild to moderate COVID-19 symptoms and a positive SARS-CoV-2 test result. Of these patients, 291 received sotrovimab and 292 received placebo within five days of the onset of COVID-19 symptoms.

To authorize the monoclonal antibody, the FDA relied on the ongoing clinical trial. Hospitalization or death occurred in 21 (7%) patients receiving placebo compared to 3 (1%) patients treated with sotrovimab, a reduction of 85%. Possible side effects of sotrovimab include allergic reactions, skin rash and diarrhea, among others (EFE/Gustavo Amador/File)

The primary endpoint was disease progression, which is defined as hospitalization for more than 24 hours for acute treatment of any disease or death from any cause up to day 29. Hospitalization or death occurred in 21 (7%) patients receiving placebo compared to 3 (1%) patients treated with sotrovimab, a reduction of 85%. Possible side effects of sotrovimab include allergic reactions, rash, and diarrhea, among others.

It was also taken into account that laboratory tests showed that sotrovimab is effective even when people with risk factors have been infected with the variants of concern. Until now the drug has not received approval or authorization in any Latin American country.

“All treatment strategies that are being developed for COVID-19 and that demonstrate benefits must be indicated at the appropriate time of the disease,” commented Dr. Cassetti. “In the case of monoclonal antibodies, their usefulness occurs at the beginning. In the case of corticosteroids, it is indicated when the patient is in critical condition. and requires oxygen. "The stage of the disease that each patient is going through must be carefully considered to indicate the appropriate treatment."

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Jorge Camargo
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