Eli Lilly seeks EUA with US Food and Drug Administration for treatment with Covid-19 antibodies


Based on new interim data and the results of previous studies, the drug company said it has submitted an application to the United States Food and Drug Administration for emergency use authorization for its treatment with unique monoclonal antibodies, and said she plans to submit an EUA application for her combination therapy in November.

In a phase 2 study, 112 people received the combination treatment and 156 received a placebo. Patients who received the combination therapy saw a statistically significant reduction in virus levels three days and seven days after treatment. The company said 0.9% of patients on treatment were hospitalized or went to the emergency room, while 5.8% of patients on placebo did.

The combination therapy was generally well tolerated and there were no serious drug-related side effects. In the monotherapy studies currently underway for EUA, known as LY-CoV555, there were “drug-related infusion-related reactions or hypersensitivity” which were generally mild. Adverse events were comparable to placebo for both monotherapy and combination therapy, the company said.

Data for single and combination therapies have not yet been published in a peer-reviewed medical journal.

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, told the UK’s Science Media Center that the data is “certainly encouraging, but preliminary” and “cautious optimism is warranted,” he said. he declares.

“The evidence for their effectiveness is encouraging but is still limited. There is more evidence that LY-CoV555 monotherapy works but that doesn’t mean it’s more effective – it’s just that it has been studied more, ”said Evans.

Li Lilly plans to have 1 million doses of her unique monoclonal antibody treatment ready for use against Covid-19 by the end of December, once the FDA grants her emergency use clearance.

“At the end of the year, we will have a million mono-therapy and next year, millions more mono-therapy or even combo-therapy, although certainly less combo than mono”, Dr Daniel Skovronsky , chief scientist of Eli Lilly, told CNN on Wednesday.

“They both had very rapid improvement in symptoms compared to placebo and there was no difference between the two,” Skovronsky said of how the therapies worked in clinical trials, but there are differences in how they can be distributed.

Between now and obtaining a possible emergency use clearance from the FDA, the only way for a Covid-19 patient to access Eli Lilly’s antibody therapies would be to participate in clinical research.

And once therapy is available, “we expect there will be no cost to patients,” Skovronsky said.

More antibody therapies under study

There are at least 70 different antibody treatments for Covid-19 under investigation.

A cocktail of monoclonal antibodies made by biotechnology company Regeneron has been used to treat President Donald Trump for Covid-19.

Trump has ties to drugmaker Regeneron - and now his stock is growing

Last week, Regeneron released the first results of tests on coronavirus patients using its cocktail of antibodies, and said the therapy appeared to reduce virus levels and improve symptoms.

The greatest improvements were seen in patients who had not yet developed a natural response to the infection, the company said.

The test results only involved 275 patients, but doctors not involved in the drug’s development said it looked promising. The treatment showed positive trends in reducing doctor visits for patients, none of whom were sick enough to be hospitalized, Regeneron said.

The figures for this first release of information were low and the data has not yet been peer reviewed. Only high level data was available in a press release from Regeneron. A company spokesperson said the data validates the treatment as a therapeutic substitute for a natural immune response to the virus.

Martin Landray, professor of medicine and epidemiology at the Nuffield Department of Population Health at the University of Oxford, said “there is a way to go” before it is clear whether drugs like Eli Lilly and Regeneron are effective against the “worst manifestations” of Covid-19 and which patients could benefit the most. And it’s hard to draw conclusions from these small studies.

“Randomized clinical trials to answer these questions are now a priority,” Landray noted. “It is encouraging to see that Eli Lilly and Regeneron have active plans for much larger trials in a range of different settings, including nursing homes, outpatients and inpatients.


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