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Eli Lilly seeks EUA from FDA for Covid-19 antibody treatment

Posted October 7, 2020 6:17 p.m. EDT

— Eli Lilly and Company's monoclonal antibody combination therapy reduced virus levels, hospitalizations and emergency room visits in patients with mild-to-moderate Covid-19, the pharmaceutical company said Wednesday.

Based on new interim data and previous study results, the pharmaceutical company said it submitted a request to the US Food and Drug Administration for emergency use authorization for its single monoclonal antibody therapy, and said it expects to submit an EUA request for its 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 the treatment were hospitalized or went to the ER, while 5.8% on the placebo did so.

The treatment also appeared to help patients' symptoms as early as three days after dosing, the company said Wednesday. The rate of COVID-related hospitalization and ER visits was lower for patients treated with combination therapy (0.9 percent) versus placebo (5.8 percent), a relative risk reduction of 84.5 percent (p=0.049).

The combination therapy was generally well tolerated and there were no drug-related serious adverse events. In studies of the monotherapy now up for an EUA, known as LY-CoV555, there were "isolated drug-related infusion reactions or hypersensitivity" that were generally mild. Adverse events were comparable to the placebo for both the monotherapy and combination therapy, the company said.

The data for the single and combination therapies has not yet been published in a peer-reviewed medical journal.

Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, told the Science Media Centre in the United Kingdom that the data are "certainly encouraging, but preliminary" and "cautious optimism is justified," he said.

"The evidence for their efficacy is encouraging but is still limited. There is more evidence that LY-CoV555 monotherapy is effective but it does not mean it is more effective -- it is just that it has been studied more," Evans said.

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

"At the end of the year we'll have a million of mono therapy and then next year, millions more of mono therapy or even a combo therapy, although certainly less combo than mono," Dr. Daniel Skovronsky, Eli Lilly's chief scientific officer, told CNN on Wednesday.

"They both had a very rapid improvement in symptoms relative to placebo and there weren't differences between the two," Skovronsky said about how the therapies performed in clinical trials, but there are differences in how they may be distributed.

Between now and being issued a possible emergency use authorization from the FDA, the only way a Covid-19 patient could access Eli Lilly's antibody therapies would be to participate in clinical research.

And once a therapy is made available, "our expectation is that there shouldn't be a cost to patients," Skovronsky said.

More antibody therapies under investigation

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

A monoclonal antibody cocktail made by the biotechnology company Regeneron was used to treat President Donald Trump for Covid-19.

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

The greatest improvements were seen in patients who had not yet mounted 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 appeared promising. The treatment showed positive trends for reducing patient medical visits, none of whom were sick enough for hospitalization, Regeneron said.

The numbers in this early release of information were small and the data has not been peer reviewed yet. Only high-level data was available in a news 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, a professor of medicine and epidemiology in the Nuffield Department of Population Health at the University of Oxford, said "there is a way to go" before it will be clear if drugs such as Eli Lilly's and Regeneron's are effective against the "worst manifestations" of Covid-19 and which patients might benefit the most. And, it's difficult to draw conclusions from such small studies.

"Randomised 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 trials in a range of different settings including residential care homes, outpatients, and hospital inpatients."

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