Most Doses of Lilly, Regeneron’s COVID-19 Antibody Treatments Are Going Unused
Moncef Slaoui, chief scientific advisor to the US government’s Operation Warp Speed program, estimates that only 5% to 20% of the roughly 65,000 doses of COVID-19 antibody treatments shipped to states around the country every week end up going to patients. He suggested this was disappointing because these therapies, viewed as a potential “bridge” to avert serious coronavirus illness until vaccines become widely available, could cut hospitalizations by half if given early enough in the course of infection.
The FDA last month issued emergency-use authorizations for Eli Lilly’s neutralising antibody bamlanivimab to treat recently diagnosed, mild-to-moderate COVID-19 in patients at high risk of progressing to severe disease and/or hospitalization, as well as for Regeneron Pharmaceuticals’ dual antibody therapy REGN-COV2, which consists of casirivimab and imdevimab administered together to treat mild-to-moderate COVID-19 in adults and paediatric patients.
US states receive a set amount of antibody treatments each week based on the number of COVID-19 cases they are reporting at the time. Health and Human Services Secretary Alex Azar echoed Slaoui’s comments on the benefits of antibodies, saying they could “dramatically reduce the risk…of hospitalizations at a time when our hospitals are getting very crowded with people with COVID-19. If you have comorbidities…if you’re at risk [of] getting into the hospital, you better get on that product as soon as possible.”
Logistical hurdles
Slaoui attributed the surplus of unused doses to the challenges of administering the antibody drugs, which is done by intravenous infusion in a hospital or outpatient setting, within a few days of patients contracting COVID-19, before they might feel sick. States and healthcare organisations have to set up safe places for patients to receive the treatment. Moreover, if patients are not getting tested or do not obtain their test results within a short window after they fall ill, they cannot benefit from the drugs.
Mr. Slaoui indicated that Operation Warp Speed may be able to help states work through those logistical hurdles, but at the moment they remain a barrier preventing patients from receiving treatment for COVID-19. He did not say whether the government will continue to ship the same quantity of the antibody drugs, or how many patients have been treated with them.
Ex-FDA chief calls for production scale-up
Meanwhile, in a recent op-ed in The Wall Street Journal, former FDA Commissioner Scott Gottlieb urged the federal government to “scale up production of antibody drugs to make as many doses as possible,” saying these could act as an “insurance policy” for COVID-19. Eli Lilly and Regeneron have teamed up with Amgen and Roche, respectively, to secure additional manufacturing capacity, which Gottlieb says will produce a combined supply of 6 million to 7 million doses next year. However, he believes “that isn’t enough,” and called on the US to help “backstop the risks to any manufacturer” by agreeing to buy and stockpile the treatments “at a price that makes it worthwhile… The government can freeze some of the active pharmaceutical ingredient and store it away as a hedge against another tough COVID winter next year.”
The US government spent $375 million on its first order of 300,000 vials of Eli Lilly’s drug, then another $812.5 million earlier this month for 650,000 more. The latter deal prompted the company this week to boost its revenue forecast for 2020. Meanwhile, Regeneron has a $450-million contract with the US for up to 300,000 doses of its antibody cocktail at no cost to patients.