FDA approves emergency treatment for COVID-19 with antibodies: what is this method

The US Food and Drug Administration (FDA) said on Monday, November 9 that it has authorized the emergency use of Eli Lilly and Co monoclonal antibody therapy for the treatment of mild to moderate coronavirus infections in adults and children. CNN.

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Treatment with a single antibody called bamlanivimab must be done in a hospital or other health care facility. It is the first monoclonal antibody approved for the treatment of COVID-19. The idea is to trigger an immune response against infection.

“Monoclonal antibodies are proteins made in the laboratory that mimic the immune system’s ability to fight harmful antigens, such as viruses. Bamlanivimab is a monoclonal antibody that is specifically directed against the SARS-CoV-2 spike protein, designed to block the virus from attaching to and entering human cells,” the FDA said in a statement.

“The FDA's emergency authorization of bamlanivimab provides healthcare providers on the front lines of the pandemic with another potential tool to treat patients with Covid-19,” said Patricia Cavazzoni, acting director of the FDA's Center for Drug Evaluation and Research. “We will continue to evaluate new data on the safety and effectiveness of bamlanivimab as they become available.”

The FDA clearance was based on a study published in October in the New England Journal of Medicine. The treatment was found to appear to reduce the risk of hospitalization and some symptoms in a small number of patients with mild to moderate cases of Covid-19.

The Phase 2 trial included 452 patients, some receiving treatment and some receiving placebo. Only 1,6% of the patients treated had symptoms that progressed to the point that they had to be hospitalized or seek help from the emergency department. For patients receiving placebo, the hospitalization rate was 6,3%.

Lilly announced that it has entered into a $ 375 million deal with the government to supply 300 vials of the drug, pending an EUA (Emergency Use Authorization), to be delivered within two months. Lilly applied to participate in the EUA in October. The company said it plans to have 000 doses ready for shipment and will produce a million doses by the end of 100. Treatment will be provided to patients free of charge.

“Lilly will immediately begin supplying bamlanivimab to national distributor AmerisourceBergen, which will distribute it in accordance with the U.S. government distribution program,” the company said in a statement.

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Emergency approval is faster than full approval

“The issuance of an EUA is different from FDA approval,” the FDA noted.

“Based on the FDA's review of all available scientific evidence, the agency has determined that there is reason to believe that bamlanivimab may be effective in treating hospitalized patients with mild to moderate Covid-19,” the FDA said. — When used to treat Covid-19, the known and potential benefits outweigh the risks for the drug. There are no adequate, approved and available alternative treatments to bamlanivimab for the authorized population."

The FDA said that treatment should be started as soon as possible after a positive test for Covid-19, within 10 days of the onset of symptoms. It should only be given in a healthcare setting where doctors also have access to medication if the patient has a bad reaction to the drug. According to the EUA, providers using this medication must also report any serious side effects to the FDA.

This treatment is not approved for patients who are hospitalized or require oxygen therapy as it does not seem to be helping them.

The hope for monoclonal antibody therapy as a potential treatment for Covid-19 has been pinned for several months.

As soon as the pandemic hit the US in January, Lilly scientists began work to identify the antibody, one of the proteins the body makes to naturally fight infection, that will best protect against the new coronavirus.
Scientists have analyzed thousands of antibodies produced by patients who have recovered from Covid-19. They found, selected, and then copied the ones that they thought would best neutralize the virus, and chose one for an advanced treatment that went into human clinical trials in June.

Regeneron has also applied for emergency use of its antibody therapy. This is the drug that President Trump was treated with last month when he contracted the coronavirus.

On the subject: Antibody cocktail and abortive cells: how Trump was treated for COVID-19

79 antibody therapies are currently under investigation.

“The approval of this new Eli Lilly antibody treatment is a significant advance in patient care and aligns us with the introduction of safe and effective vaccines,” said Health and Human Services Commissioner Alex Azar.

Lilly is also testing bamlanivimab in combination with another monoclonal drug it has developed. A peer-reviewed study in August found that the Regeneron cocktail, which used two antibodies to treat it, worked in the laboratory even when the new coronavirus mutated.

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