Eli Lilly’s Antibody Treatment Testing On Hold Over Safety Concerns
NIH paused clinical trials of Eli Lilly's monoclonal antibody treatment after one of the study groups "crossed a safety threshold." Separately, Reuters reports that FDA investigators discovered quality control issues at a plant manufacturing the experimental therapeutic.
Stat:
NIH Paused Eli Lilly Covid-19 Antibody Trial Because Of Safety Concerns
It could be two weeks until there is news on a paused trial of Eli Lilly’s closely watched monoclonal antibody treatment for Covid-19. The National Institutes of Health said late Tuesday that it paused the trial because one of the two groups in the study — one had received the antibody, the other a placebo — was doing better than the other. Both groups also received remdesivir, a Covid-19 treatment from Gilead Sciences. (Garde and Herper, 10/13)
Reuters:
Exclusive: FDA Faults Quality Control At Lilly Plant Making Trump-Touted COVID Drug
U.S. drug inspectors uncovered serious quality control problems at an Eli Lilly and Co pharmaceutical plant that is ramping up to manufacture one of two promising COVID-19 drugs touted by President Trump as “a cure” for the disease, according to government documents and three sources familiar with the matter. The Lilly antibody therapy, which is experimental and not yet approved by regulators as safe and effective, is similar to a drug from Regeneron Pharmaceuticals that was given to the president during his bout with COVID-19. Trump, who credits the Regeneron drug with speeding his recovery, has called for both therapies to become available immediately on an emergency basis, raising expectations among some scientists and policy experts that the administration will imminently release an Emergency Use Authorization (EUA) for the drug. (Levine and Taylor, 10/13)
Also —
The Wall Street Journal:
J&J Hopes Covid-19 Vaccine Trial Will Restart Shortly
Johnson & Johnson hopes to know within days whether it can resume testing its Covid-19 vaccine, as the health-products company battles the virus on several fronts. An independent committee is investigating the unexplained illness of a study volunteer that prompted a pause in clinical trials of the company’s experimental Covid-19 vaccine, J&J Chief Financial Officer Joseph Wolk said in an interview Tuesday. The illness is “still under investigation and we’re going to let that process play out,” Mr. Wolk said. The company is hopeful that the pause will only last a few days, he said. (Loftus, 10/13)
Stat:
Covid-19 Study Pauses At J And J, Lilly Could Be Hard Bumps — Or Mere Blips
Here is what we know about drugs and vaccines: If tested in rigorous clinical trials and shown to be safe and effective, they make the world a healthier place. Here is another thing we know about drugs and vaccines: They are not easy to develop. (Garde, 10/13)
USA Today:
COVID Vaccine Trials Are On Hold. Why Experts Say That's Reassuring.
Recent pauses to two large-scale COVID-19 vaccine trials and a treatment study should reassure people — not frighten them — vaccine experts said, though it is a reminder of the messiness of science. “This is an indication that the system is working as it was designed to work to protect human subjects in clinical trials,” Lawrence Gostin, a public health and legal expert at Georgetown and Johns Hopkins universities, said Tuesday. “It demonstrates that the ethical guard rails on vaccine trials are working.” (Weintraub and Weise, 10/13)
