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U.S. should build up antibody therapy supply, ex-FDA chief says

UPDATED: Sun., July 5, 2020

By Cristin Flanagan Bloomberg News

The United States should be building up reserves of therapeutic antibodies now ahead of any potential approval or emergency use authorization to treat the coronavirus, said the former head of the U.S. Food and Drug Administration.

“We need a more coordinated national strategy around this,” ex-FDA Commissioner Scott Gottlieb said on CBS’s “Face the Nation” on Sunday.

Gottlieb said the U.S. government could encourage drugmakers to curtail production of less essential medicines for a time, in favor of making more antibody treatments now.

A handful of drugmakers and academic centers are racing to test new antibody treatments from the blood of recovered COVID-19 patients. Eli Lilly & Co. and Regeneron Pharmaceuticals Inc. are in the lead of developing so-called neutralizing antibodies that can mimic immune responses to the virus, and may report some of the first results in the third quarter.

Lilly is working with closely held AbCellera Biologics Inc., while AstraZeneca Plc and Vir Biotechnology Inc. are testing new treatments.

The government should be working with companies ahead of time to make sure enough supplies are available, the former FDA head said. “That’s what should be happening, particularly around the antibodies. We missed the window to do it on remdesivir,” he said, referring to Gilead Sciences Inc.’s drug that received the agency’s emergency use authorization in May.

As it stands, the U.S. may have enough of Gilead’s drug for now, but if the pandemic worsens and doctors seek to use remdesivir beyond the scope of its current label, particularly in patients with pre-existing conditions before they become very sick, the U.S. missed the window and won’t have enough medicine for that, Gottlieb said.

Gottlieb had cautious words about the upcoming fall and winter and the likely incidence of the coronavirus, even as the U.S. continues to log record daily numbers of cases.

“We’re not going to be able to crush this virus at this point because there’s so much infection around, and we really don’t seem to have the political will to do it,” he said.

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