- The U.S. government has paused distribution of Eli Lilly's combination COVID-19 antibody drug nationwide due to the spread of coronavirus variants that weaken its potency.
- The two variants, known as Beta and Gamma and first identified in South Africa and Brazil, respectively, now account for more than 11% of the sequenced cases in the U.S. and are trending upwards. Lab tests show Lilly's drug is "not active" against both variants, unlike rival drugs from Regeneron and Vir Biotechnology, according to a letter from the U.S. Assistant Secretary for Preparedness and Response.
- The decision by U.S. officials is the biggest blow yet to Lilly's COVID-19 efforts. Since last year, the Food and Drug Administration has authorized two different Lilly COVID-19 antibody drugs for emergency use. But both have had trouble neutralizing certain variants, including the combination regimen that was specifically designed to counter the virus's evolutionary tricks.
The speedy rise and potential fall of Lilly's COVID-19 antibody drug franchise is exceedingly unusual by drug industry standards.
Drugmakers typically need more than a decade to bring a new medicine to market. And when successful, companies are usually able to reap the financial rewards for years as their products enjoy patent protection.
But both sides of that journey were hyper-compressed in Lilly's case, a testament to the company's successful clinical development efforts as well as the difficulty containing a once-in-a-century pandemic.
Like others early last year, Lilly quickly began working on a COVID-19 antibody drug in the early stages of the coronavirus outbreak. Teaming with China's Junshi Biosciences and Canadian biotech AbCellera, the company developed two different types of medicines: a single antibody drug, and a dual-antibody combination.
The two-pronged strategy appeared to give Lilly a leg up on competition from Regeneron, Vir Biotechnology and others. The single antibody, bamlanivimab, is easier to manufacture and distribute than a combination. But a fast-following two-drug regimen — bamlanivimab and a second antibody, etesevimab — was meant to be more potent and better able to deal with viral mutations.
Lilly was first to market when the FDA cleared bamlanivimab for emergency use in November, and the company followed up with a second authorization of the dual-antibody regimen in February. Both proved, in Phase 3 trials, that they could sharply reduce hospitalizations and deaths in COVID-19 patients at high-risk of poor health outcomes. Lilly has generated some $2 billion in revenue from their use.
But their shelf life could be short. Two months after the FDA cleared Lilly's combination regimen, the U.S. government stopped distributing bamlanivimab, citing the spread of certain variants the drug couldn't neutralize. The FDA then pulled its authorization of bamlanivimab in April upon Lilly's request, a process the drugmaker had put in motion thinking its dual antibody would perform better. Lilly Chief Scientific Officer Dan Skovronsky called the move a "planned transition" in a statement on the move.
Lilly's two-drug combination, however, began having similar problems shortly thereafter. In May, the U.S. halted shipments of the treatment to Illinois, Massachusetts and a few other states over variant concerns. The spread of variants has since escalated to the point that nationwide rollout of the drug has been stopped altogether, with providers now directed to administer Regeneron and Vir's treatments across the country. Both have been able to neutralize the variants that have emerged so far.
In a statement, Lilly indicated that it isn't giving up on the bamlanivimab-etesevimab combination. The drugmaker noted the prevalence of variants varies by "state, region and even country and can change rapidly." Lilly will work with regulators "to ensure our antibodies are available to the appropriate patients" as variants evolve and their transmissions patterns change, the company added.