The FDA will meet outside experts later this month at a gathering expected to reveal data about potential vaccines.
US drugmaker Eli Lilly and Co said on Tuesday that the government-sponsored clinical trial of its COVID-19 antibody treatment has been paused because of a safety concern.
“Out of an abundance of caution, the ACTIV-3 independent data safety monitoring board (DSMB) has recommended a pause in enrollment,” Lilly spokeswoman Molly McCully said in an emailed statement. “Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study.”
Lilly’s drug is similar to the Regeneron Pharmaceuticals, Inc treatment US President Donald Trump received after he contracted COVID-19.
Lilly had already asked US regulators to authorise its antibody therapy, LY-CoV555, for emergency use after publishing data in September that showed it helped cut hospitalisation and emergency room visits for COVID-19 patients. The treatment is being developed with Canadian biotech AbCellera.
Lilly shares were down nearly 3 percent amid the news on Tuesday, with the COVID-19 vaccine setback weighing on Wall Street.