COVID-19 antibody drugs not a cure, but seem promising
WASHINGTON — They’re not cures and it’s not likely that everyone will be able to get them as President DonaldTrumphassuggested.
But experimental antibody drugs like the one Trump was given are among the most promising therapies being tested for treating and preventing coronavirus infections.
Eli Lilly and Regeneron Pharmaceuticals Inc. are asking the U.S. government to allow emergency use of their antibody drugs, which aim to help the immune system clear the virus. The medicines are still in testing; their safety and effectiveness are not yet known.
Trump is among fewer than 10 people who were able to access the one by Regeneron under “compassionate use” rules, without enrolling in a study.
How do they work? Antibodies are proteins the body makes when an infection occurs; they attach to a virus and help it be eliminated. Vaccines mimic an infection to spur antibody production.
But it can take several weeks after a vaccine or natural infection for the most effective antibodies to form. The experimental drugs are concentrated versions of specific antibodies that worked best against the coronavirus in lab and animal tests.
In theory, they start helping right away. The one-time treatment is given through an IV — it’s not like a pill that people can take at home.
How do the drugs differ? Regeneron is using two antibodies to enhance chances its therapy will work even if the virus evades one. The company made a successful Ebola combo treatment this way.
Lilly is testing two differentantibodies— onewiththe CanadiancompanyAbCellera and another with a Chinese aimtoprevent serious illness, complications or death.
Researchersalsoaretesting these drugs to try to prevent infectioninpeopleathighrisk of it, such as health workers, housemates of people with COVID-19, andnursinghome workers and residents.
Will there be enough for everyone? It depends onhow potent the drugs prove to be, something still being studied. If a high dose is needed to be effective, it will mean that fewer people can be treated with limited supplies. Regeneron says it has enoughdoses for approximately 50,000 patients andexpects 300,000 available within the next few months.
Under a $450 million contract, the federal governcompany, JunshiBiosciences menthasagreed to buyinitial — individually and in combisupplies of Regeneron’s nation. Others testing similar drug and distribute them drugs are GlaxoSmithKline at no cost to U.S. patients. and Vir Biotechnology Inc., Lilly says it expects to have which says it has engineered 1 million doses this year of antibodies to last longer than the single antibody that it they usually do. submitted to FDA. However,
Amgen, Adaptive Biotechthe company’s research has nologies and the Singapore focused on a combination biotech company Tychan of two antibodies to treat Pte Ltd. also have studies COVID-19 patients. Lilly said underway. it expects to have just 50,000
Whenmight they be availdoses of that combothis year. able? Eli Lilly and RegenWhat’s the evidence eron have asked the Food that they work? Lilly and and Drug Administration for Regeneron have revealed emergency authorization. only partial results in news During public health emerreleases; they haven’t been gencies the FDA can speed published or vetted by indedrugs to market based on a pendent scientists. lower standard of evidence Lilly said last week that than is normally required. its two-antibody combo
Drugmakers need only reduced symptoms, the show that the expected amount of virus, hospibenefits of their therapies talizations and ER visits outweigh the risks for treatfor patients with mild or ing COVID-19. There is no moderate COVID-19. deadline for the FDAto rule The results are an interim on the drugs, but it typically look at a mid-stage study in makes decisions on such which 112 people received emergency applications the antibodies and 156 got a within days or weeks. placebo.
Who would get them? The amount of virus was Researchers are still trying significantly lower 11 days to determine the best candilater in those given the drug dates for antibody treatment. — the main goal of the study. Some studies involve newly About 5.8% of patients infected people to see if early given placebo required treatment can lower the risk hospitalization or an emerof becomingsick. Other studgency roomvisit versus 0.9% ies with hospitalized patients of those given the antibodies.