Studies extend hopes for antibody drugs against COVID-19
(Eli Lilly via AP)New results extend hopes for drugs that supply antibodies to fight COVID-19, suggesting they can help keep patients out of the hospital and possibly prevent illness in some uninfected people. Separately, Regeneron Pharmaceuticals Inc. said partial results from an ongoing study suggest its drug combo completely prevented symptomatic infections in housemates of someone with COVID-19. The need for an infusion has greatly limited the use of antibody drugs in the pandemic because of health care shortages. U.S. regulators have allowed emergency use of some Lilly and Regeneron antibodies for mild or moderate COVID-19 cases that do not require hospitalization while studies of them continued. Lillyโs new results were from a study of 1,035 non-hospitalized patients recently diagnosed with COVID-19.
Demand is low for COVID-19 antibody drugs but shortages loom
FILE - This photo provided by Eli Lilly shows the drug Bamlanivimab, the first antibody drug to help the immune system fight COVID-19. Red tape, staff shortages, testing delays and strong skepticism are keeping many patients and doctors from these drugs, which supply antibodies to help the immune system fight the coronavirus. Ironically, government advisers met Wednesday and Thursday to plan for the opposite problem: potential future shortages of the drug as COVID-19 cases continue to rise. The drugs aim to help right away, by supplying concentrated doses of one or two antibodies that worked best in lab tests. Eli Lilly and Regeneron Pharmaceuticals have emergency authorization to supply their antibody drugs while studies continue.
Henry Ford receives Eli Lilly antibody treatment, readies freezers for COVID-19 vaccine
DETROIT โ There is new hope that a coronavirus vaccine is closer than ever to making its way to Metro Detroit. Henry Ford Hospital said it could see its first doses being delivered in upcoming weeks, and they have the specialized freezers and equipment ready to go for when a COVID-19 vaccine arrives. Additionally, doses of Eli Lillyโs monoclonal antibody treatment have arrived. Dr. Adnan Munkarah, the chief clinical officer of the Henry Ford Health System, discussed the antibody treatment and preparing for the arrival of vaccines. Weโre learning more about how quickly the coronavirus vaccine could be rolled out.
Eli Lilly granted emergency use authorization for COVID-19 antibody therapy
DETROIT โ There has been some positive news in the search for a coronavirus (COVID-19) treatment. Eli Lilly has been granted emergency use authorization for its monoclonal antibody therapy. Itโs similar to the drug by Regeneron that was used to treat President Donald Trump. Eli Lillyโs monoclonal antibody treatment for COVID-19 has authorization to treat mild to moderate COVID-19 in patients who are not hospitalized but are at high risk. The drug is an artificially produced antibody that neutralizes the spike protein on the SARS-CoV-2 virus.
US allows 1st emergency use of a COVID-19 antibody drug
WASHINGTON โ U.S. health officials have allowed emergency use of the first antibody drug to help the immune system fight COVID-19, an experimental approach against the virus that has killed more than 238,000 Americans. The Food and Drug Administration on Monday cleared the experimental drug from Eli Lilly for people 12 and older with mild or moderate COVID-19 not requiring hospitalization. Early results suggest the drug, called bamlanivimab, may help clear the coronavirus sooner and possibly cut hospitalizations in people with mild to moderate COVID-19. Regeneron Pharmaceuticals Inc. also has asked for emergency authorization for an antibody drug it is testing, the one Trump received. FDA regulators authorized the Lilly drug using their emergency powers to quickly speed the availability of experimental drugs and other medical products during public health crises.
Asian stocks fall on worries over rising virus cases, US aid
People wearing face masks walk past a bank's electronic board showing the Hong Kong share index in Hong Kong, Wednesday, Oct. 28, 2020. Asian shares headed lower Wednesday on worries about rising virus counts and Washington's inability to deliver more aid to the economy. (AP Photo/Kin Cheung)Asian shares headed lower Wednesday on worries about rising virus counts and Washington's inability to deliver more aid to the economy. Japan's benchmark Nikkei 225 fell 0.3% in morning trading to 23,420.93, while South Korea's Kospi declined 0.2% to 2,325.22. The U.S. dollar weakened to 104.30 Japanese yen from 104.41 yen late Tuesday.
Lilly antibody drug fails in a COVID-19 study; others go on
U.S. government officials are putting an early end to a study testing an Eli Lilly antibody drug for people hospitalized with COVID-19 because it doesnโt seem to be helping them. Independent monitors had paused enrollment in the study two weeks ago because of a possible safety issue. In a statement Lilly notes that the government is continuing a separate study testing the antibody drug in mild to moderately ill patients, to try to prevent hospitalization and severe illness. The company also is continuing its own studies testing the drug, which is being developed with the Canadian company AbCellera. Lilly and Regeneron have asked the U.S. Food and Drug Administration to grant emergency use authorization for their drugs for COVID-19 while late-stage studies continue.
Possible safety issue spurs pause of COVID-19 antibody study
The paused study, called ACTIV-3, started in August and aims to enroll 10,000 hospitalized COVID-19 patients in the United States, Denmark and Singapore. The pause in the Lilly study comes a day after a temporary halt to enrollment in a coronavirus vaccine study. Johnson & Johnson executives said Tuesday that it will be a few days before they know more about an unexplained illness in one participant that caused a pause in its late-stage vaccine study. Johnson & Johnson isnโt disclosing the nature of the illness. He says Johnson & Johnson gave information on the case to the independent monitoring board overseeing the safety of patients in the study, as the research protocol requires.
Drug shows promise in 1st largely minority COVID-19 study
A drug company said Friday that a medicine it sells to tamp down inflammation has helped prevent the need for breathing machines in hospitalized COVID-19 patients in the first large study that primarily enrolled Hispanics and Blacks. The drug, given through an IV, tamps down a protein called interleukin-6 thatโs often found in excess in COVID-19 patients. About 12% given the drug needed a breathing machine or died within 28 days versus about 19% of patients given a placebo. This is the third time this week that companies have announced positive results from studies testing COVID treatments via press releases. On Monday, Eli Lilly reported benefits from a study testing its anti-inflammatory drug baricitinib when combined with the antiviral drug remdesivir.
Study hints antibody drug may cut COVID-19 hospitalizations
A drug company says that partial results from a study testing an antibody drug give hints that it may help mild to moderately ill COVID-19 patients from needing to be hospitalized, a goal no current coronavirus medicine has been able to meet. He had no role in the Lilly study but helps direct antibody studies for a public-private research group the federal government formed to speed testing of these drugs. The study will continue to test the antibody drug in combination with another from a Chinese company, Junshi Biosciences. Lilly has already started manufacturing its antibody drug, hoping to have hundreds of thousands of doses ready by fall if studies give positive results. Another company that developed an antibody drug cocktail against Ebola โ Regeneron Pharmaceuticals Inc. โ now is testing a two-antibody drug for coronavirus.
Anti-inflammatory drug may shorten COVID-19 recovery time
A drug company says that adding an anti-inflammatory medicine to a drug already widely used for hospitalized COVID-19 patients shortens their time to recovery by an additional day. Eli Lilly announced the results Monday from a 1,000-person study sponsored by the U.S. National Institute of Allergy and Infectious Diseases. All study participants received remdesivir, a Gilead Sciences drug previously shown to reduce the time to recovery, defined as being well enough to leave the hospital, by four days on average. Those who also were given baricitinib recovered one day sooner than those given remdesivir alone, Lilly said. Lilly said it planned to discuss with regulators the possible emergency use of baricitinib for hospitalized COVID-19 patients.
Companies test antibody drugs to treat, prevent COVID-19
The antibody drugs are โvery promisingโ and, in contrast, could be available โfairly soon," said Dr. Janet Woodcock, a U.S. Food and Drug Administration official who is leading government efforts to speed COVID-19 therapies. One company, Eli Lilly, has already started manufacturing its antibody drug, betting that studies now underway will give positive results. Another company that developed an antibody drug cocktail against Ebola โ Regeneron Pharmaceuticals Inc. โ now is testing one for coronavirus. Others working on antibody drugs include Amgen and Adaptive Biotechnologies. All the antibody drugs must make their way through the bloodstream to wherever theyโre needed.