Amid record levels of new Covid-19 infections and hospitalizations, the Food and Drug Administration announced on Saturday that this would allow emergency use drug therapy called an antibody RAIN-COV2 which helps the immune system fight the virus.
The treatment, developed by biotech company Regeneron, consists of two antibodies called casirivimab and imdevimab which have so far shown promise in reducing the severity of the coronavirus when given to patients who have not yet developed symptoms requiring hospitalization. Another similar treatment, carried out by drug giant Eli Lilly, was approved earlier this month.
The Regeneron treatment received wide attention after it was used to treat President Donald Trump during his battle with the virus in October. In a video posted Oct. 7, Trump claimed – without evidence – that the treatment had cured him and said his administration was working on an Emergency Use Authorization (EUA). Trump also appeared to claim, falsely, that he had already authorized its use, even though he does not have the authority to authorize drugs.
At the time, some doctors and experts have turned to Twitter wonder why the president’s doctors would give him a treatment not yet approved by the FDA. As Julia Belluz of Vox explained, “Trump was only able to access treatment through the The Compassionate Use of the FDA provision for unapproved drugs to be administered on a case-by-case basis to critically ill patients who have no other treatment options. “
The new FDA approval of the drug cocktail means it will be available for use by more people, including those who would not have qualified for compassionate use. And it comes on the heels of pressure from several Trump administration officials, including White House Chief of Staff Mark Meadows, and President Jared Kushner’s son-in-law, who publicly pushed FDA Commissioner Dr. Stephen Hahn for quick reviews of the agency.
However, the treatment will not be widely available immediately: according to Regeneron, the company will have enough medicine for 80,000 people by the end of November, 200,000 in early January and 300,000 in late January. A partnership with the Swiss drug manufacturer Roche will then increase production.
It remains to be seen whether these doses will be sufficient to meet demand. The United States is in the midst of a record spate of cases, with more than 1 million new cases of Covid-19 being diagnosed last week. Records for most new confirmed cases within a day are regularly broken and hospitals are increasingly at risk of being overwhelmed.
The FDA also recommended that the cocktail be used only under certain circumstances. The agency says only people aged 12 or older who are at increased risk of developing severe cases of Covid-19 should receive treatment.
And according to Regeneron, the results of two trials show that the treatment works when given early in a patient’s treatment process, before they have developed severe symptoms. The FDA also said that the antibodies are not allowed for anyone who has been hospitalized or needs oxygen; Regeneron said studies are continuing to better understand the effects of treatment on hospital patients.
The company has received more than $ 500 million from the U.S. government for the development of the treatment as part of the Trump administration’s Operation Warp Speedand with this funding, the first 300,000 doses are supposed to be provided free of charge. Patients will still be responsible for paying for the administration of treatment – antibodies are delivered intravenously, which means that treatment will need to be performed by healthcare professionals in hospitals or clinics.
The benefits of REGN-COV2 from Regeneron are still not proven
The emergency approval is coming like a hype over two possible Covid vaccines that have recently gained a lot of attention. Pfizer, creator of one of the vaccines, said it had successfully completed its clinical trial and submitted an emergency FDA request for approval on Friday, while another company, Moderna, said it would soon do so. a demand. Health officials had hoped that antibody treatments like Regeneron would help treat cases before vaccines became widely available.
Regeneron’s antibody cocktail is just one of many such experimental treatments for Covid-19. There is also convalescent plasma, which is taken from people who have been infected with the virus but who later recovered, as Umair Irfan from Vox explained:
Plasma is the liquid part of blood, including proteins used for clotting, and when taken from convalescents, it contains antibodies to the virus. So transfusion of plasma from a person who has recovered to a sick person might help them get better or prevent them from getting sick in the first place.
These treatments are still under study, in particular REGN-COV2 from Regeneron. As Irfan explained:
The FDA can grant an EUA to allow unapproved medical products to treat or prevent serious illness when there are no suitable alternatives on the market.
The benchmark for an EUA is lower than that of full license approval. In general, the treatment in question should have a likely benefit, while approval requires proof of proven advantage.
In practice, this means that the FDA is not entirely sure that Regeneron treatment is working, but that it is “reasonable to believe that casirivimab and imdevimab taken together may be effective in treating patients with the condition.” mild or moderate COVID-19. ” Before showing up for his EUA, Regeneron said he plans to continue trials in which a variety of hospitalized and non-hospitalized individuals.
This uncertainty has led some health experts to criticize the expedited process for approving potential viral treatments. In September, the National Institutes of Health criticized the FDA’s emergency clearance for convalescent plasma, saying, “There is insufficient data to recommend or against the use of convalescent plasma.”
At this time, peer-reviewed research has yet to be published on Regeneron’s antibody treatment, so experts can only trust the data presented in company press releases claiming to show that the treatment is working. The FDA believes it has seen enough of it to allow its use, however, giving doctors one more option to consider as cases increase.