- The U.S. government has paused distribution of Eli Lilly's combination COVID-19 antibody drug in Massachusetts due to the growing prevalence of a coronavirus variant that is less susceptible to treatment.
- The variant, first identified in Brazil, is circulating with more than 10% frequency in the state, according to the U.S. Assistant Secretary for Preparedness and Response. As a result, the government advised the area's healthcare providers to prescribe an antibody cocktail from Regeneron instead. Lilly's double antibody regimen was shown to be weaker against the variant in lab tests.
- The decision is another blow to Lilly's COVID-19 efforts. The FDA, on Lilly's request, already revoked an emergency clearance for the company's single antibody drug due to variant concerns. Lilly's drug combination, which was cleared earlier this year, was designed to better protect against viral mutations.
Lilly's response to COVID-19 has been among the industry's most successful. The company created, tested and won emergency clearances for two antibody drugs, as well as proving another of its other medicines can help treat the disease, too.
The Indianapolis drugmaker's single antibody, bamlanivimab, was the first treatment of its kind when the FDA cleared it for emergency use in November after the company proved it could help keep infected patients out of the hospital. Authorization of Lilly's two-drug combination followed in February, and the agency has sanctioned the company's anti-inflammatory drug baricitinib for use in hospitalized COVID-19 patients.
Those results have boosted Lilly's business. The company earned $810 million from its COVID-19 antibody drugs last quarter and $871 million in the three months to end 2020. While the first quarter total was lower than what analysts expected, Lilly's revenues have outpaced those of Regeneron, which booked $262 million in the first quarter for its COVID-19 antibody treatment.
Demand for antibody drugs could be ebbing in the U.S., however. Lilly has already forecasted lower use of its antibody drugs in 2021 due in part to the broad availability of vaccines. Mutations to the original coronavirus strain, meanwhile, have given rise to variants that may be less susceptible to antibody treatment.
The U.S. government stopped distributing bamlanivimab in March after the drug was found to be significantly less potent against multiple variants of concern. The FDA revoked its clearance for bamlanivimab just a month later, although Lilly had set that process in motion believing its dual antibody treatment could perform better.
Unlike bamlanivimab, the two-drug combination can latch onto the coronavirus in more than one place. That strategy is meant to account for viral mutations and the possibility the coronavirus could eventually evade treatment. Lilly has said its combination regimen can neutralize emerging variants better than bamlanivimab alone. Regeneron, by comparison, started with a dual antibody regimen rather than pursue a monotherapy approach.
Lilly and Regeneron's combination regimens have performed differently against key variants, most notably ones first detected in South Africa and Brazil, known respectively as B.1.351 and P.1. Lilly's drug is "unlikely to be effective" against both variants, according to the fact sheet on its authorization. That's become problematic of late, as P.1 is circulating at "persistently elevated" levels of more than 20% in Illinois and, more recently, over 10% in Massachusetts, according to the ASPE.
The U.S. government, as a result, has stopped distributing the combination in both states and is recommending providers choose Regeneron's drug, which is "likely to retain activity" against P.1, the ASPE wrote.
In an emailed statement to BioPharma Dive, Lilly noted the prevalence of variants of concern vary "by state and can change rapidly." A variant that originated in California and about a month ago was dominant in a few states, for example, has declined in prevalence in recent weeks.
Lab tests indicate the combination regimen "maintains its neutralizing effect against the vast majority of COVID-19 cases seen across the country today," Lilly's spokesperson wrote, including the so-called B.1.1.7 variant that makes up about 70% of U.S. cases. The combination reduced hospitalizations and death by 87% in high-risk COVID-19 patients in a Phase 3 trial carried out in the U.S. as new strains were emerging, the spokesperson noted.
The spokesperson didn't indicate whether Lilly would consider withdrawing the combination, should variants of concern spread further.
"As variants continue to evolve and their patterns of transmission and prevalence shift, we will continue our work with governments and regulators worldwide to assure that the right antibodies are available to the right patients, in the right places, and at the right time," the spokesperson said.