- Eli Lilly's combination antibody treatment reduced the risk of hospitalization or death from COVID-19 by 87% in a Phase 3 study, a new set of data that helps to solidify the therapy's benefits.
- The trial, called BLAZE-1, compared a placebo with the two-drug regimen of Lilly antibody drugs recently cleared by the Food and Drug Administration for emergency use. A previous set of data compared placebo with higher doses of the drugs, called bamlanivimab and etesevimab, and found a 70% reduction in death and hospitalization. Lower doses, however, can stretch limited supplies further.
- This new study subset looked at patients age 12 and older with mild-to-moderate COVID-19 but who were at high risk for complications. No deaths were reported among the 511 patients given the combination therapy, compared with four among the 258 patients given a placebo. Four patients on the Lilly treatment needed to be hospitalized, versus 15 in the placebo group.
While nearly all of the focus on the coronavirus pandemic in recent months has been on the rollout of vaccines, there are still thousands of patients hospitalized with COVID-19 each week.
Lilly’s combination therapy is one of only a few available antibody drugs meant to keep infected patients from getting sicker and needing professional care. But they remain significantly underutilized, in part because initial data supporting their authorization was relatively sparse. The latest findings could help reinforce the benefits of antibody treatments, especially those given in combination.
Lilly’s single antibody treatment, bamlanivimab, is also available for use under an emergency FDA clearance issued last year. But the combination regimen targets the coronavirus in multiple ways, likely providing a stronger defense against viral mutations. Regeneron had the same goal in mind when it designed its antibody cocktail, which the FDA also cleared for emergency use last year.
With viral variants surging in the U.S. and around the world, and their effects on vaccination unclear, the need for antibody drugs to keep COVID-19 patients out of the hospital may still be significant. The Biden administration late last month acknowledged that need when it agreed to buy 100,000 doses of Lilly’s combination therapy for $210 million.
The National Institutes of Health, meanwhile, updated its guidelines to recommend use of Lilly’s combination treatment for high-risk patients, saying treatment should begin as soon as possible and before patients are hospitalized. European regulators also issued a positive opinion.
The potential market for Lilly’s drug is "still underappreciated," Cantor Fitzgerald analyst Louise Chen wrote in a note to investors. Sales of Lilly’s antibody treatments may top $2 billion this year, she wrote.
But to get there, developers need additional data and to clear some of the logistical obstacles to greater use of antibody therapy. Lilly, for instance, has worked to reduce the infusion time needed for the medicines, which need to be administered in a healthcare setting. The company now says bamlanivimab alone can be administered in as little as 16 minutes, while the combination can be infused in just 21 minutes. Previously, the FDA said infusions should take an hour.
To date, the U.S. government has allocated more than 660,000 doses of bamlanivimab to local jurisdictions.