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Eli Lilly seeks EUA from the US Food and Drug Administration for the treatment of Covid-19 antibodies



Based on new interim data and the results of previous studies, the pharmaceutical company said it has filed an application with the U.S. Food and Drug Administration for emergency use authorization for its single monoclonal antibody therapy and said he expects to submit an EUA application for his 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 at 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 the placebo did.

The combination therapy was generally well tolerated and no serious drug-related adverse events occurred. In monotherapy studies currently available for an EUA, known as LY-CoV555, generally mild “isolated drug-related infusion reactions or hypersensitivity”

; occurred. 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 Science Media Center in the UK that the data is “certainly encouraging, but preliminary” and “cautious optimism is warranted,” he said.

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

The first human trial of a potential antibody treatment for Covid-19 begins

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Li Lilly plans to have 1 million doses of her single monoclonal antibody therapy ready for use against Covid-19 in late December, once the FDA grants her an emergency use authorization.

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

“Both had very rapid improvement in symptoms compared to placebo and there were no differences between the two,” Skovronsky said about how the therapies were performed in clinical trials, but there are differences in how they can be distributed.

From now until the FDA has issued an emergency use authorization, the only way a Covid-19 patient could access Eli Lilly’s antibody therapies would be to participate in clinical research.

And once therapy is available, “our expectation is that there shouldn’t be a cost to patients,” Skovronsky said.

Other antibody therapies under study

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

A cocktail of monoclonal antibodies produced by the biotech company Regeneron was used to treat President Donald Trump for Covid-19.

Trump has ties to drug maker Regeneron and his stock is now on the rise

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

The greatest improvements were seen in patients who had not yet fitted 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 to reduce patient visits, none of whom were ill enough for hospitalization, Regeneron said.

The numbers in this early release of information were small, and the data has not yet been peer-reviewed. Only high-level data was available in a Regeneron press release. 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 Oxford University’s Nuffield Department of Population Health, said “there is a way to go” before it is clear whether drugs like Eli Lilly’s and Regeneron’s are effective against. ” the worst manifestations “of Covid-19 and which patients could benefit most from it. And it is difficult to draw conclusions from such small studies.

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


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