Paul Mango, deputy chief of staff for policy at the US Department of Health Human Services, said, “I can tell you that we currently – as of today – have access to a couple hundred thousand doses of the monoclonal antibodies.”
“We expect that volume to exceed a total of a million before year-end 2020,” he said during a Friday briefing.
Mango declined to provide further details, saying, “I think it’s a little bit market sensitive to talk about which manufacturer has what,” he said. He added that if an emergency use authorization is granted, “We will have enough to take care of the Americans that need that from a clinical perspective, and that production will continue to ramp up as we go throughout the fall.”
Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, tampered expectations a bit, reminding the US, “How many doses [are] available of a therapeutic depends on the actual milligram dose that is show to be effective,” as well as the patient population across the nation.
Earlier in the briefing, Woodcock said, “We feel like the early indications of antiviral activity and potential impact on the clinical course of disease is very promising.”
“Of course we will see what decisions the FDA makes about perhaps making these more widely available,” she said. “In the meantime we continue to study these antibodies we plan to study more of them in our master protocols that we have ongoing.”
Some context: Eli Lilly and Company’s monoclonal antibody combination therapy reduced virus levels, hospitalizations and emergency room visits in patients with mild-to-moderate Covid-19, the pharmaceutical company said Wednesday.
Based on new interim data and previous study results, the pharmaceutical company said it submitted a request to the US Food and Drug Administration for emergency use authorization for its single monoclonal antibody therapy, and said it expects to submit an EUA request for its combination therapy in November.