Amid record levels of new Covid-19 infections and hospital stays, the Food and Drug Administration announced on Saturday that the use of an antibody drug treatment known as REGN-COV2, which helps the immune system fight the virus, would be approved in an emergency.
The treatment, developed by biotech company Regeneron, consists of two antibodies called casirivimab and imdevimab, which so far have shown promising results in reducing the severity of the coronavirus in patients who have not yet experienced symptoms that require hospitalization. Another similar treatment from drug giant Eli Lilly was approved earlier this month.
Regeneron treatment gained widespread attention after it was used to treat President Donald Trump during his battle with the virus in October. In a video released Oct. 7, Trump claimed – with no evidence – that the treatment cured him and said his administration was working on an Emergency Authorization (EEA). Trump also appeared to be falsely claiming that he had already approved it for use despite not having the authority to approve drugs.
At the time, some doctors and experts took to Twitter to ask why the president’s doctors would give him treatment that had not yet been approved by the FDA. Julia Belluz of Vox stated, “Trump could only access treatment through the FDA’s” Compassionate Use “provision, in which unapproved drugs are administered to critically ill patients who have no other treatment options on a case-by-case basis.”
The new FDA approval of the antibody cocktail means it will be available to a greater number of people, including those who would not have qualified for compassionate use. This comes under pressure from several Trump administration officials, including Mark Meadows, White House Chief of Staff, and Jared Kushner, the President’s son-in-law, FDA Commissioner Dr. Stephen Hahn publicly urged the agency for quick reviews.
Treatment won’t be available immediately, however: Regeneron said the company will have enough of treatment for 80,000 people by the end of November, 200,000 by early January, and 300,000 by the end of January. A partnership with the Swiss drug manufacturer Roche will then enable production to increase.
It remains to be seen whether this will be enough to meet demand. The US is in the midst of a record-breaking spate of cases. More than 1 million new Covid-19 cases were diagnosed in the past week. The records for most new confirmed cases in one day are regularly broken, and hospitals are increasingly at risk of being overwhelmed.
The FDA has recommended that the cocktail only be used under certain circumstances. The agency says only those who are 12 years of age or older and are at an increased risk of developing severe cases of Covid-19 should receive treatment.
And according to Regeneron, the results of two studies show that the treatment works when given early in a patient’s treatment process, before serious symptoms develop. The FDA also stated that the antibodies are not approved for people who have been hospitalized or need oxygen. Regeneron said studies continue to better understand the effects of treatment on hospitalized patients.
The company received more than $ 500 million from the U.S. government to develop the treatment as part of the Trump administration’s Operation Warp Speed. Due to this funding, the first 300,000 cans will be made available free of charge. Patients are still responsible for paying for treatment – the antibodies are given via an infusion, which means treatment must be administered by healthcare professionals in hospitals or clinics.
The benefits of REGN-COV2 from Regeneron have not yet been proven
The emergency clearance comes as two possible Covid-19 vaccines have received a lot of attention lately. Pfizer, maker of one of the vaccines, said it recently successfully completed its clinical trial and filed an application for emergency approval with the FDA on Friday, while another company, Moderna, said it would apply soon. Health officials had hoped antibody treatments like Regeneron’s would help treat cases in time before vaccines become widely available.
Regeneron’s antibody cocktail is just one of several such experimental treatments for Covid-19. There is also convalescent plasma taken from people who were infected with the virus but later recovered, as Umair Irfan of Vox explained:
Plasma is the liquid part of blood, including the proteins used to clot, and when harvested by convalescents it contains antibodies to the virus. Transfusing plasma from someone who has recovered to someone who is sick could help them get better or prevent them from getting sick in the first place.
These treatments are still being investigated, including Regeneron’s REGN-COV2. As Irfan explained:
The FDA can issue an EUA that allows unapproved medical devices to treat or prevent serious illnesses when there are no adequate alternatives on the market.
The benchmark for an EUA is lower than for the full approval of the license. In general, the treatment in question must have a likely benefit, while approval requires evidence of a proven benefit.
In practice, this means that the FDA is not entirely sure whether the treatment for Regeneron will work, but that it “is reasonable to believe that casirivimab and imdevimab, given together, can be used in the treatment of patients with mild or moderate COVID -19 can be effective “. Prior to filing for the EEA, Regeneron said it planned to continue the studies, which involved a wide range of people with and without hospitalization.
This uncertainty has led some health professionals to raise concerns about the rapid-track process for approving potential viral treatments. In September, the National Institutes of Health criticized the FDA’s emergency approval for convalescent plasma, saying, “There is insufficient data to recommend either for or against the use of convalescent plasma.”
No peer-reviewed research on Regeneron antibody treatment has yet been published. Experts can therefore only refer to data contained in company press releases in which the treatment work is to be shown. However, the FDA believes it has seen enough to approve its use, which gives doctors another option to consider as cases rise.
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