- Eli Lilly's antibody treatment for COVID-19 can now be used to treat certain individuals who have been exposed to someone infected with the coronavirus, or are at high risk of an exposure due to where they work, such as in a nursing home or prison.
- The authorization granted by the Food and Drug Administration, announced by Lilly Thursday, expands on an existing clearance to use the company's combination regimen to treat infected individuals who are at high risk for severe disease.
- With the clearance, Lilly's antibody treatment can now be used in similar settings as Regeneron's competing therapy. Both are in high demand as surging COVID-19 cases drive increased use of synthetic antibodies, particularly in states with lower vaccination rates.
The FDA's new authorization of Lilly's COVID-19 treatment comes the same week as the U.S. government agreed to buy nearly 1.8 million antibody doses from the Indianapolis drugmaker and Regeneron. While the treatments were underutilized for months, the spread of the delta variant, together with lagging vaccination rates, have led to shortages.
In response, the federal government has also shifted how it allows states to order doses it's purchased, moving away from a direct ordering system back to the centrally managed process that was in place last fall and winter.
Having both Lilly's and Regeneron's treatments now cleared for similar uses could help with that allocation, particularly as shipments from the companies stretch over the next several months.
Lilly's new authorization applies to its combination treatment that pairs two antibodies: bamlanivimab and etesevimab. Bamlanivimab, which was the first to win FDA approval, remains withdrawn from the market due to the ability of prevalent coronavirus variants to evade its reach.
Viral escape from treatment was also an issue for Lilly's dual antibody regimen, but only for the beta and gamma variants that have yielded ground to the more infectious delta variant. Use of the combination treatment is limited to areas where the frequency of resistant variants is less than 5%.
High-risk individuals aged 12 years or older are eligible to receive the combination treatment following an exposure to an infected person if they either haven't been fully vaccinated, or if they are not expected to have a sufficient immune response to full immunization.
The authorization is based on results from a study Lilly conducted called BLAZE-2, which tested bamlanivimab alone as a preventive treatment post-exposure. Results showed people who were given the antibody contracted COVID-19 at a lower rate than those who did not. Among a sub-group of nursing home residents, treatment was associated with up to an 80% reduction in risk.
Regeneron won FDA authorization for post-exposure prevention use in August. In both cases, the regulator cautioned that antibodies, which don't provide long-lasting protection, are not a substitute for vaccination.