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US stocks up on COVID-19 antibody drugs amid shortage concerns

The antibody treatments from Regeneron and Eli Lilly have been proven effective in reducing the risk of hospitalization or death from COVID-19 in certain high-risk individuals who have already been infected. Regeneron’s treatment is also authorized by the Food and Drug Administration for limited preventive use in people who have come in contact with an infected individual.

For many of the months since they were cleared by the FDA, the treatments were relatively little used, particularly as vaccinations picked up in the spring of 2021. Lilly’s single antibody treatment and later its combination treatment of etesevimab and bamlanivimab were both withdrawn after testing data showed reduced efficacy versus the beta and gamma variants.

But as delta has spread, they are being turned to more and more frequently, particularly in states where vaccination rates are lower. Last month, the U.S. also restarted distribution of Lilly’s combination treatment, which has proved in laboratory testing to remain effective versus delta.

According to reporting by The Washington Post, seven states — Alabama, Florida, Texas, Mississippi, Tennessee, Georgia and Louisiana — have used 70% of the overall antibody drug supply in recent weeks. All but Florida have lower than average vaccination rates, the Post noted.

In response to stepped-up demand, the Health and Human Services Department put in ordering limits early this month and, on Monday, moved to resume its role in managing distribution. As a result, states can no longer directly order through distributor AmerisourceBergen.

“The increased incidence of the Delta variant of SARS-CoV-2 has caused a substantial surge in the utilization of monoclonal antibody drugs, particularly in areas of the country with low vaccination rates,” the agency said in a Sept. 13 statement. “HHS is committed to helping ensure consistent availability of these critical drugs for current and future patients in all geographic areas of the country.”

The department will send out 158,580 doses of Regeneron’s antibody treatment this week as well as 17,880 doses of Lilly’s combination regimen, which can only be used in areas where the combined frequency of variants resistant to it are less than 5%.

The new supply contracts are windfalls for the two companies. Regeneron will earn more than $2.9 billion from the new deal, while Lilly will receive $330 million in revenue.

The U.S. previously bought more than 1.5 million doses from Regeneron, and nearly 1 million doses of Lilly’s bamlanivimab. But with use of bamlanivimab alone discontinued, the federal government wanted more supply of the partner antibody etesevimab, too.

Roche will help manufacture one-third of the supply coming from Regeneron under an existing production partnership.