US Health Authorities Halt Eli Lilly COVID Antibody Treatment Trial Over "Safety Concerns"

Similar to Regeneron Treatment Used for Trump
Announcement Following Johnson & Johnson Vaccine Clinical Trial Halt...Concerns Over Development Delays

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Hyunwoo Lee] U.S. pharmaceutical company Eli Lilly announced that its Phase 3 clinical trial for a novel coronavirus disease (COVID-19) antibody treatment has been halted following recommendations from U.S. health authorities due to potential safety concerns. This comes a day after Johnson & Johnson's COVID-19 vaccine trial was paused, raising growing concerns that the development of COVID-19 treatments may face delays.

According to foreign media including CNBC, on the 13th (local time), the Data and Safety Monitoring Board (DSMB), which oversees the safety of vaccines and treatments developed by pharmaceutical companies, recommended halting the enrollment in the clinical trial of Eli Lilly's COVID-19 monoclonal antibody treatment due to potential safety issues. Consequently, Eli Lilly has fully suspended its ongoing Phase 3 clinical trial. Molly McCully, a spokesperson for Eli Lilly, told CNBC in an interview, "Safety is the most important issue," and added, "We understand that the board recommended pausing enrollment as a precaution." The specific safety concerns raised have not been disclosed.

Eli Lilly was conducting the 'ACTIV-3' clinical trial, part of the National Institutes of Health (NIH)-sponsored ACTIV (Accelerating COVID-19 Therapeutic Interventions and Vaccines) program, to evaluate the safety and efficacy of the monoclonal antibody treatment alongside remdesivir developed by Gilead Sciences. This trial is also known to be supported by the Trump administration's 'Operation Warp Speed' program.

The monoclonal antibody treatment was developed using blood samples from patients who recovered from COVID-19 and is based on a similar principle to Regeneron's antibody treatment, which was used as one of the therapies for President Trump's COVID-19 infection. President Trump publicly praised the antibody treatment's effectiveness after his discharge. Subsequently, Eli Lilly reportedly accelerated development efforts, including submitting an emergency use authorization application for the antibody treatment to the U.S. Food and Drug Administration (FDA) on the 8th.

The news of Eli Lilly's clinical trial suspension came just one day after Johnson & Johnson announced the halt of its COVID-19 vaccine trial, intensifying concerns that the pace of COVID-19 vaccine and treatment development may slow down.

This content was produced with the assistance of AI translation services.