The Food and Drug Administration of the USA (FDA, for its acronym in English) granted an emergency authorization for the experimental antibody treatment that was given to President Donald Trump last month. when he tested positive for covid-19.
The drug, manufactured by Regeneron Pharmaceuticals, is designed to prevent infected people from developing serious illness. Instead of waiting for the body to develop its own protective immune response, the drug mimics the body’s natural defenses. It is the second drug of this type, called a monoclonal antibody, to be authorized to fight COVID-19.
The FDA authorized the drug from Eli Lilly & Co. on November 9.
Regeneron’s drug is a cocktail of two monoclonal antibodies, called casirivimab and imdevimab. The FDA said in authorizing the cocktail that the drugs can be effective in treating mild to moderate COVID-19 in adults and children 12 years and older., and are indicated for those at high risk of developing a serious disease. Doctors hope the drugs will prevent those patients from being hospitalized.
But just like with Lilly’s treatment, Regeneron drug is a biological product that is complicated and time consuming to produce; so initially there will be little availability. The shortage, coupled with the complexities of administering intravenous medication, have raised concerns about whether those most in need will be able to obtain it.
Regeneron executives said 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 Regeneron’s experimental drug, a cocktail of two antibodies, on October 2 after he was diagnosed with covid-19 and began showing symptoms. The drug was provided to him through a compassionate use program, also called expanded access, which allows people to obtain unapproved drugs. Chris Christie, the former Republican governor of New Jersey who also had covid-19, was given access to the drug Lilly, called bamlanivimab.
In tweets and videos after he was released from the hospital, Trump incorrectly described the Regeneron drug as a cure and lobbied the FDA to quickly authorize the drug. However, it took several weeks before the agency took action.
Monoclonal antibodies, which are made in laboratories, are proteins that mimic the immune system’s ability to attack the virus. Regeneron’s covid-19 drug is made in genetically modified hamster cells.
In a study published October 28 in the journal New England Journal of Medicine, the researchers said The Lilly cocktail lowered risk during follow-up medical visits and lowered virus levels in people with mild to moderate symptoms of COVID-19.
Progress in monoclonal antibodies occurs as pharmaceutical and biotech companies rush to produce coronavirus vaccines. Pfizer and Moderna could obtain emergency authorization for their vaccines before the end of the year; Pfizer applied for clearance from the FDA on Friday. But it will take months to vaccinate the population of the United States, and much more the world. Vaccines may not work for everyone. In any case, antibody treatments can play an important role in making the disease less dangerous.
However, if the pandemic continues, there will not be enough antibody treatments for everyone who could benefit from them. Unlike conventional pills, these drugs are synthesized by living organisms in specialized reactors, at a biological rate that cannot be rushed. There is a global struggle to find the capacity to make the drugs, and companies have entered into agreements with competitors to increase their manufacturing capabilities.
Through Operation Warp Speed in conjunction with the Trump administration’s effort to speed up treatments and vaccines, the government purchased 300,000 doses each from Lilly and Regeneron at a cost of around $ 1,250 and $ 1,500 per dose, respectively. with the option to buy hundreds of thousands more doses. However, this occurs as the nation approaches 200,000 new coronavirus cases each day.
But, in a sign of how quickly supplies could run out as the pandemic escalates across the country, 40 percent of Lilly’s bamlanivimab doses have already been allocated to states. In just two weeks, the US government has already assigned almost 120,000 of the 300,000 doses.
Due to the 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 communication, the Secretary of Health and Human ServicesAlex Azar said that antibody treatments have “the potential to save thousands of lives and significantly reduce the burden of disease on the health care system.”
It is unclear where the antibody drugs will be administered, particularly as patients will be contagious and the drug cannot be administered in established infusion clinics alongside patients with compromised immune systems.
“They cannot be sent to places where cancer patients are treated.”said Mark McClellan, director of the Duke-Margolis Center for Health Policy and a former FDA commissioner. He said many hospital systems have additional space that they could dedicate to antibody treatments, or they could establish emerging centers. Home infusion providers like CVS could administer the drug in nursing homes and nursing homes, he said.
Due to the expected shortage, doctors have expressed concern that the drugs are not being distributed equitably or reaching the patients who need them most, especially in disadvantaged communities.
Trump administration officials, at the recent briefing, promised to distribute the treatment fairly and quickly, basing distribution on a strategy similar to that used for remdesivir, an antiviral drug for hospitalized patients. The administration’s launch of remdesivir was fraught with problems in its early stages. Doctors reported a confusing and unfair process, clouded by incomplete medical information. Some doses went to the wrong hospitals, to medical centers without intensive care units and therefore without eligible patients, and to facilities without the necessary refrigeration for storage, meaning that some doses were returned to the government.
Trump administration officials said they had learned from those mistakes
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