Lilly, with new data, seeks emergency clearance for COVID-19 antibody drug

Dive Brief:

  • Eli Lilly has asked the Food and Drug Administration to approve an experimental antibody drug for emergency use in treating COVID-19, making it the first of an emerging class of medicines to be submitted to public health regulators.
  • Lilly aims to use one of its antibodies in higher-risk patients recently diagnosed with mild-to-moderate cases of COVID-19. But the drugmaker on Wednesday shared new findings suggesting a combination of two antibodies may help treat COVID-19 patients as well. Lilly plans to ask for emergency clearance of that regimen in November, and file for a standard approval as early as the second quarter of 2021.
  • The announcement comes days after President Donald Trump received another COVID-19 antibody treatment from Regeneron, and adds to the drugs’ recent momentum as potentially critical tools in curbing the pandemic. Engineered antibody drugs could potentially both treat COVID-19 and protect someone who has been exposed to the coronavirus.

Dive Insight:

Eli Lilly and Regeneron have been neck and neck for months in a race to prove the worth of antibody drugs for COVID-19. Both began human testing in June, and both disclosed the first clinical results from those trials in September, data that suggested their antibodies may help patients with mild disease clear the virus, shake off symptoms and avoid the hospital.

For much of that time, antibody drugs have taken a backseat in the public eye to coronavirus vaccines, which could deliver the type of long-lasting protection needed to end the pandemic. Engineered antibodies, by comparison, might provide weeks or months of benefit by mimicking the effects of a natural immune response to infection.

Over the past week, however, these antibody drugs have taken center stage. On Oct. 1, the White House disclosed that Trump had been treated with Regeneron’s therapy under compassionate use, immediately raising its profile and leading to speculation that it might be on the verge of an emergency use authorization, or EUA.

Now, Lilly appears to have jumped in front of Regeneron to make that request, revealing it is discussing potential approvals with other countries as well.

Initial data from the company in June came from study of a single experimental antibody, an approach that differed from Regeneron’s two-antibody combination, which is meant to grab the virus more firmly and make viral escape less likely.

On Wednesday, though, Lilly revealed the first results for its own antibody cocktail. The data are limited, coming via snippets of information from a press release, rather than from a publication in a peer-reviewed medical journal. But they suggest Lilly’s combination helped reduce hospital trips, emergency room visits and levels of the virus in symptomatic COVID-19 patients who haven’t yet been hospitalized.

In the study, 112 patients received 2,800 milligrams of each Lilly antibody, while 156 got a placebo. The drug led to statistically significant reductions in levels of the virus after 3, 7 and 11 days — the last of which was the study’s main goal.

Lilly noted, however, that most patients, including those on placebo, cleared the virus after 11 days.

More importantly, less than 1% of patients who received Lilly’s combination made a COVID-19 related trip to the hospital or emergency room, compared to 5.8% of placebo-treated patients — a nearly 85% reduction in relative risk.

That finding is only so strong, due to the small size of the trial. The seeming benefit would carry more weight if reproduced in larger, more definitive tests. Nonetheless, analysts and experts were encouraged by the results.

“Given the mechanism seems right and it’s a big effect, I think the probability that it is real is high,” said Walid Gellad, an associate professor at the University of Pittsburgh and a director of the Center for Pharmaceutical Policy and Prescribing there. “We obviously need more data, but for the criteria for an EUA, this seems like it should qualify.”

In a note to clients, Brian Skorney, an analyst at R.W. Baird, wrote the results “may provide proof-of-concept” that lowering levels of virus with an antibody could translate to improved health outcomes.

If proven, that would make for an important advance in the fight against COVID-19. Already, Gilead’s Veklury and the steroid dexamethasone have been shown in studies to help people hospitalized with the disease. Regeneron and Lilly have now begun to make a case for antibodies in patients with mild symptoms. Having each of those tools available could make a difference in easing the pandemic’s burden while the world waits for an effective vaccine.

It’s unclear as of yet who exactly would be in the “higher-risk” group Eli Lilly may be cleared to treat — the answer will come via discussions with the FDA, said chief scientific officer Dan Skovronksy, on a conference call. But the company aims to define them by age and weight — like a subset of results it provided in obese patients over 65 with a high body-mass index. 

This strategy appears to contrast with Regeneron, which noted recently its best results were in people who hadn’t mounted a natural immune response or had high levels of virus — characteristics that would require specific testing to find. 

“Given the difficulty of testing in today’s environment, the selection of high risk patients based on age and weight seems simple to us,” CEO Dave Ricks said. 

Perhaps the biggest constraint facing antibody drugs is the production capacity of their developers. Lilly, for instance, said it could supply about 1 million doses of its monotherapy treatment this year, with 100,000 available this month. Just 50,000 courses of the combination treatment would be ready this year, though the supply would increase substantially in 2021.

Lilly is working with Amgen to help boost its supply and said it is pursuing additional manufacturing partnerships as well.

Skovronksy said the company is testing lower doses of its antibodies to see if the company can stretch its supply even further. 

Editor’s note: This story has been updated with comments from Eli Lilly executives. 

Ned Pagliarulo contributed reporting.

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