Regeneron has stopped enrolling critically ill Covid-19 patients in clinical trials of antibody therapy, which US President Donald Trump has welcomed as a “cure” for the disease.
Regeneron’s share fell by as much as 3% after an independent data monitoring committee warned that the risks could outweigh the benefits of patients hospitalized with high levels of oxygen.
The move is because Eli Lilly, who is also developing Covid-19 antibody therapy, found it unlikely that the group would benefit after discontinuing trials in hospitalized patients earlier this week.
The two companies filed an emergency license application with the US Food and Drug Administration to treat patients with mild to moderate Covid-19, a category that includes Mr. Trump, who became ill earlier this month.
Dan Lucy, an infectious disease specialist at Georgetown University, said regulators should convene a committee of external advisors before issuing an emergency permit that has never been granted a monoclonal antibody. ..
“The FDA needs to carefully examine safety evidence and whether the treatment actually works to avoid the emergence of replication errors that have issued an emergency permit for hydroxychloroquine and convalescent plasma,” he said. Stated.
Regeneron trials continue in outpatients and inpatients with hypoxia or anoxia, suggesting that safety concerns are most limited to sick participants. However, because the drug is given as an IV drip, it can be difficult to distribute to less ill patients who are not hospitalized.
Eric Topol, director of the Scripps Research Translational Institute, said that while it makes biological sense that the treatment was effective in attacking the virus, it treats the body’s own potentially excessive immune response to the disease. He said he didn’t.
“There are smaller windows, the sooner the better,” he said, adding that more serious patient safety issues did not raise concerns about patients with mild to moderate Covid-19.
The Eli Lilly antibody trial in inpatients was initially discontinued due to safety concerns in early October. But when the company announced on Monday that it would abandon that division of the trial, it said the safety differences between the groups were not important.
The US government has already signed a contract to supply both treatments that strengthen the body’s immune system with artificially produced antibodies. Regeneron has a $ 450 million contract to manufacture and supply antibody cocktails, while Eli Lilly announced its first $ 375 million agreement earlier this week.
Mr. Trump was treated with Regeneron when he was suffering from an illness. In a video in early October, he praised the drug, suggesting that he was feeling better soon and was about to be approved. Regeneron’s CEO, Leonard Schleifer, occasionally played golf with the president.
Antibody treatment can be an important tool for physicians. Despite investing in clinical trials, there are still few options to treat Covid-19, and there are concerns about how well Gilead’s remdesivir, the only antiviral drug approved by US regulators, works. There is.
Geoffrey Porges, an analyst at SVB Leerink, said he was “very confident” that antibody treatment would receive urgent approval. He said it can still have a market of about 40 to 50 percent of inpatients.
In a Friday noon trade in New York, Regeneron shares fell 2.6% to $ 541.31 and Eli Lilly fell 1.6% to $ 130.44.
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