CNN’s Andrea Kane posted an excellent article on monoclonal antibodies yesterday. Since we have lots of information here on what they do, and why they are important, we will focus on her coverage of the current issues that are preventing them from being leveraged sufficiently to save lives.
(CNN) There are very few drugs that prevent people with early Covid-19 from progress to severe disease, but monoclonal antibodies may be among them. Early study results show they may reduce the rate of hospitalizations by up to 70% if they are taken in time, which can be life-saving, especially among people who are at high risk of getting very sick. But it seems that the word is not getting out to those who need the medications the most, or their health care providers.
Eli Lilly’s monoclonal antibody, called bamlanivimab, received an emergency use authorization from the US Food and Drug Administration in early November. Less than two weeks later, the agency granted an EUA to Regeneron’s monoclonal antibody cocktail, made up of two monoclonal antibodies, casirivimab and imdevimab, and called REGEN-COV2. It was given to President Trump when he got infected at the start of October. Former New Jersey Gov. Chris Christie and Housing and Urban Development Secretary Ben Carson were also treated with monoclonal antibody therapy.
According to the FDA, monoclonal antibodies should be given as soon as possible after symptoms emerge and a person tests positive for infection. And, because of limited supply, the authorizations are limited to high-risk patients, such as people 65 and older, those who have a BMI (body mass index) of 35 or greater and those with other health conditions like diabetes, cardiovascular disease or chronic kidney disease.”The monoclonal antibodies we’ve authorized seem to work best for preventing hospitalization in outpatients early in their disease — typically within 10 days of the onset of symptoms, if you are a high-risk individual. So, over the age of 65, or over the age of 55 with a comorbidity, or… some preexisting illness to put you at risk,” FDA Commissioner Dr. Stephen Hahn told CNN’s Dr. Sanjay Gupta in mid-December.”
These antibodies, for the last month since authorization, have been distributed around the country. So, they should be available locally, and it’s under state jurisdiction,” Hahn said. At a time when hospitals across the country are running out of beds and staff to care for the severely ill, monoclonal antibodies may have a real role to play. So why aren’t more people trying to access these potentially life-saving medications, especially since both the drugs are mostly free, under Operation Warp Speed?
Covid-19 antibody therapies show promising early results in separate trials. “We’ve got to get the therapeutics used. We need patients who test positive, who are at risk of hospitalization, to get on these monoclonal antibodies. We actually have more right now than there are getting used. We’ve got to get them earlier, so we keep people out of hospitals,” Health and Human Services Secretary Alex Azar told CNN’s Jake Tapper Monday. An HHS spokesperson confirmed that a new report showed only 5%-20% of the available supply of monoclonal antibodies are actually being used — an ironic statistic considering one big concern was that there would not be enough supply to meet demand. It is the first time HHS had requested utilization information from facilities and providers administering the drugs.” We will continue working with stakeholders to learn more about drug utilization decisions,” the spokesperson said.
Azar told reporters at an Operation Warp Speed briefing in mid-December that more than 278,000 courses of the two antibody treatments have gone out to medical facilities, and that the administration is working to send out more. The government initially bought 300,000 doses of bamlanivimab and in early December bought an additional 650,000 doses, according to an Eli Lilly statemen, which also says it “continues to manufacture bamlanivimab for use around the world, and the supply is expected to increase substantially in 2021.” A release from Regeneron notes it “expects to have treatment doses ready for approximately 80,000 patients by the end of November, approximately 200,000 patients by the first week of January, and approximately 300,000 patients in total by the end of January 2021.”
While that may sound like a lot of doses in total, they come at a time when new coronavirus cases in the United States alone are averaging more than 215,000 per day — although it’s important to note that not everyone who is infected has risk factors for developing severe disease and so may not be a candidate for one of these medications. Both companies told CNN in separate emails that supply is expected to increase in 2021 as additional manufacturing resources “scale up” (Regeneron) and “come online” (Eli Lilly).In addition to Lilly and Regeneron’s monoclonal antibody medications, there are more than 70 different antibody treatments for Covid-19 under investigation, according to BIO, an association that represents major biotechnology companies.