Health
Former FDA Prime Minister says US should increase supply of antibody therapy | Nation/World
Former director of the US Food and Drug Administration said the United States should now build up therapeutic antibodies in advance of approval for coronavirus treatment and approval for emergency use.
“We need a more coordinated national strategy around this,” former FDA commissioner Scott Gottlieb told CBS on “Face the Nation.”
Gottlieb said the US government is now in favor of giving more antibody therapies and could encourage pharmaceutical companies to temporarily cut back on the production of less important drugs.
Only a handful of pharmaceutical companies and academic centers are competing to test new antibody therapies from the blood of recovered COVID-19 patients. Eli Lilly & Co. and Regeneron Pharmaceuticals Inc. are leading the development of so-called neutralizing antibodies that can mimic the immune response to the virus and may report some of the first results in the third quarter.
Lilly is working closely with Ab Cellera Biologics Inc., where AstraZeneca Plc and Vir Biotechnology Inc. are testing new therapies.
Former FDA leaders said the government would need to work with companies in advance to ensure that sufficient supplies are available. “That’s what’s really going to happen with the antibody in particular. We’ve missed the window to do that with lemdesibir,” he told Gilead Sciences, which received agency approval for use in May. I mentioned and said.
At present, the United States may well have Gilead’s drug, but if the pandemic worsens and doctors try to use lemdesibir beyond the scope of the current label, especially before becoming severe. In patients with pre-existing conditions in the United States, Gottlieb said the United States had missed windows and not enough medication for that.
Gottlieb warned about the upcoming fall and winter and possible outbreaks of the coronavirus, despite the US continuing to record daily case numbers.
“There are so many infectious diseases around that we can’t get rid of the virus at this point and we don’t seem politically willing to do it,” he said.
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