Home https://server7.kproxy.com/servlet/redirect.srv/sruj/smyrwpoii/p2/ Business https://server7.kproxy.com/servlet/redirect.srv/sruj/smyrwpoii/p2/ The Regeneron antibody cocktail given to Trump is approved for general use

The Regeneron antibody cocktail given to Trump is approved for general use

Regeneron is a cocktail of two monoclonal antibodies called kazirivimab and imdevimab. The FDA said in approving the cocktail that the drugs may be effective in treating mild to moderate covid-19 in adults and children 12 years of age and older and are indicated for those at high risk of developing severe disease. Doctors hope the drugs will prevent these patients from being hospitalized.

But as with Lilly treatment, Regeneron is a biological product that is complex and time consuming; it will initially be in short supply. The shortage, combined with the complexity of administering the intravenous drug, has raised concerns about whether people in greatest need will be able to receive it.

Regeneron executives said in their call for profit in early November that the company plans to have enough doses for 80,000 patients by the end of November and 300,000 total doses by the end of January.

Trump received an infusion of the study drug Regeneron ̵

1; a cocktail of two antibodies – on October 2, after he was diagnosed with covid-19 and began to show symptoms. He received the drug through a compassionate use program, also called extended access, which allows people to receive unauthorized drugs. Chris Christie, the former Republican governor of New Jersey, who also had covid-19, gained access to a Lilly drug called bamlanivimab.

In tweets and videos after his discharge from the hospital, Trump incorrectly described the drug Regeneron as a cure and pressured the FDA to quickly clear the drug. It was several weeks before the agency took action.

Monoclonal antibodies, which are prepared in laboratories, are proteins that mimic the ability of the immune system to attack the virus. Regeneron’s covid-19 is produced in cells from genetically modified hamster cells.

In a study published Oct. 28 in the New England Journal of Medicine, researchers said the Lilly cocktail reduced the risk of subsequent medical visits and reduced virus levels in people with mild to moderate symptoms of covid-19.

Advances in monoclonal antibodies are coming as pharmaceutical and biotechnology companies compete to produce coronavirus vaccines. Pfizer and Moderna may receive an emergency permit for their vaccines by the end of the year; Pfizer is applying for FDA approval on Friday. But it will take months to vaccinate the population of the United States, much less the world, and the shots may not work for everyone. In any case, antibody treatment can play an important role in making the disease less dangerous.

However, if the pandemic continues to rage, there will not be enough antibody treatment for anyone who can benefit from it. Unlike conventional pills, these drugs are synthesized by living organisms in specialized reactors, at a biological rate that cannot be accelerated. There is a global struggle to find capacity to produce drugs, with companies entering into deals with competitors to increase their production capacity.

Through Operation Warp Speed, the Trump administration’s efforts to speed up treatment and vaccines, the government purchased 300,000 doses of Lilly and Regeneron, at about $ 1,250 and $ 1,500 per dose, respectively, with the ability to purchase hundreds of thousands of doses. More ▼. But that comes as the nation approaches 200,000 new cases of coronavirus every day.

But as a sign of how quickly the supply can be spent as the pandemic grows across the country, 40 percent of Lily’s bamlanivimab doses have already been distributed to states. In just two weeks, the US government has dispensed nearly 120,000 of the 300,000 doses.

Due to limited supply, the number of doses each state receives will be determined by the number of confirmed cases and hospitalizations in a given week, federal officials said.

In a recent briefing, Health and Humanitarian Services Minister Alex Hazard said that antibody treatment had “the potential to save thousands of lives and significantly reduce the severity of the disease on the health system.”

It is not clear where the antibody drugs will be administered, especially because patients will be contagious and cannot receive the drug in established infusion clinics with patients with impaired immune systems.

“You can’t send them to places where cancer patients are being treated,” said Mark McClellan, director of the Duke Margolis Center for Health Policy and a former FDA commissioner. He said many hospital systems have extra space that they can set aside for antibody treatment or set up pop-up centers. Home infusion providers, such as CVS, can administer the drug in nursing homes and nursing homes, he said.

Due to the expected shortage, doctors expressed concerns that medicines would not be distributed fairly or would find their way to patients who needed them most, especially in disadvantaged communities.

During a recent briefing, Trump administration officials promised to distribute treatment fairly and quickly, based on the distribution of a strategy similar to that used for remdezivir, an antiviral drug for hospitalized patients. The administration of remdezivir by the administration was affected by problems in the early stages. Doctors report a confusing and unfair trial overshadowed by incomplete medical information. Some doses went to the wrong hospitals, to hospitals without intensive care units and therefore without eligible patients, as well as to facilities without the necessary refrigerated storage, which means that some doses were returned to the government.

Trump administration officials say they have learned from these mistakes.

“William One contributed to this report.”

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