Based on new interim data and the results of previous studies, the pharmaceutical company said it had received a letter from U.S. Submitted a request to the Food and Drug Administration for authorization of emergency use for its single monoclonal antibody therapy and said it expects the EU to submit a request for its combination therapy. November.
In a Phase 2 study, 112 people received combination treatment and 156 placebo. Patients receiving combination therapy showed statistically significant reductions in virus levels after three days and seven days of treatment. The company said 0.9% of the patients treated were hospitalized or went to the ER, while 5.8% of those on the placebo did so.
Combination therapy was generally well tolerated and there were no serious drug-related adverse events. In a study of monotherapy called EUA (LU-CoV555), there were “different drug-related infusion reactions or hypersensitivity” that were generally mild. Anti-events were comparable to monotherapy and combination therapy with both placebo, the company said.
Data for single and combination therapy have not yet been published in a peer-reviewed medical journal.
“Evidence for their effectiveness is encouraging but it is still limited. There is more evidence that LY-CoV555 monotherapy is effective but that does not mean that it is more effective – it is just that it has been studied more,” Evans said. .
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Li Lilly plans to take 1 million doses of its single monoclonal antibody treatment for use against Covid-19 in late December, once the FDA approves it for emergency use.
“At the end of the year we will have one million mono therapies and next year, mono therapy or even combo therapy, but definitely less combo than mono,” Daniel said. Daniel Schwronski, Ally Lily’s chief scientific officer, told CNN on Wednesday.
“Both had a much faster improvement in symptoms compared to placebo and there was no difference between the two,” Schworski said of how the treatments were performed in clinical trials, but there were also differences in how they were distributed.
Between now and possible approval of emergency use from the FDA, the only way Covid-19 patient Eli Lilly could access antibody therapy is to participate in clinical research.
And once the treatment becomes available, “our expectation is that there should be no cost to patients,” Schworski said.
Further antibody therapy under investigation
There are at least 70 different antibody treatments for Covid-19 under investigation.
A monoclonal antibody cocktail made by biotechnology company Regeneron was used for Covid-19 to treat President Donald Trump.
Last week, Regenero released the results of a preliminary examination on coronavirus patients using its antibody cocktail, saying the treatment reduces virus levels and improves symptoms.
The highest improvement was seen in patients who have not yet responded naturally to the infection, the company said.
Only 275 patients were involved in the test results, but doctors who were not involved in the development of the drug said it looked promising. Treatment showed positive trends in reducing the patient’s medical visits, none of which were sick enough to be hospitalized, Regeneron said.
The number of releases of this initial information was low and the peer of the data has not yet been reviewed. Only high-level data was available in a news release from Regeneron. A company spokesman said the data validated the treatment as a therapeutic alternative to the natural immune response to the virus.
“There’s a way,” said Martin Landrey, a professor of medicine and epidemiology at Oxford University’s Newfield Department of Population Health. The manifestations of Covid-19 “and which patients may benefit the most. And, it is difficult to draw conclusions from such a small study.
“Comfortable clinical trials are now a priority to answer these questions,” Landre noted. “It is encouraging to see that both Eli Lilly and Regeneron have active plans for a much larger trial in a range of different settings, including residential care homes, outpatients and hospital patients.”
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