Eli Lilly’s Covid-19 drug bamlanivimab is no longer distributed in 3 states because of a variant, Woodcock says
The US government is no longer distributing Eli Lilly’s bamlanivimab into California, Arizona and Nevada because of the prevalence of a viral variant that is not susceptible to the monoclonal antibody, FDA acting commissioner Janet Woodcock told physicians taking part in a webinar with the American Medical Association on Wednesday.
Woodcock did not elaborate further on the variant or the decision to halt the distribution, but overall, the FDA remains uniquely positioned to screen the monoclonals against the different variants, Woodcock added, and that’s been predictive of how and where the treatments will work.
A Lilly spokesperson told Endpoints News in a statement: “We recognize the U.S. government has made the decision to no longer allow direct ordering of bamlanivimab alone in California, Arizona and Nevada due to concerns about the prevalence of the ‘California’ variant, with the specific L452R substitution found in B.1.429/B.1.427 lineages (a.k.a. 20C/CAL.20C). Importantly, preclinical data from our labs demonstrate that the combination of bamlanivimab and etesevimab maintains its neutralizing effect against this variant, specifically.”
Overall, Woodcock acknowledged that the initial rollout of the monoclonal antibodies “wasn’t the greatest” because it was centered on a distribution model for Gilead’s antiviral remdesivir, and “hospitals were in no position to give out monoclonals.”
“We’re getting there but it’s taken quite a long time,” Woodcock said in reference to the monoclonal antibodies in the US. “Mass vaccination is hard enough but mass infusion is a real challenge for our health care system.”
John Farley, director of the FDA’s office of infectious diseases, said that the FDA expects to soon broaden the definition of who falls into the “high risk” category that determines who can receive the monoclonal antibodies.
“We know from the field that we would benefit by broadening this a bit and we’re expecting to do that soon,” he said.
He also said that the three authorized monoclonal antibodies remain active against the variant originating in the UK, but there are “other, more worrisome variants” and physicians should expect to soon see more information on those.
As far as the wider therapeutic landscape for Covid-19, Woodcock again noted the fact that just 5% of clinical trials for Covid-19 treatments were adequately powered and randomized to provide actionable data.
“Low accrual rates and inadequate power mean that safety and efficacy data will be uninterpretable,” she said. She also criticized the slow rollout of the NIH-run trials for Covid-19 therapeutics.
Overall, she explained some of the major challenges that she saw as head of therapeutics at Operation Warp Speed, and moving forward, she discussed what a robust ecosystem for clinical trials in the US would look like.