United States Should Increase Supply of Antibody Therapy, Says Former FDA Chief

(Bloomberg) –

© Photographer: Toya Sarno Jordan / Bloomberg
Commissioner of the Food and Drug Administration (FDA) Scott Gottlieb listens during a hearing of the House of Representatives Oversight and Investigations Subcommittee in Washington, DC, USA, on Thursday, March 8, 2018.

The United States should be accumulating stocks of therapeutic antibodies now before any potential approval or authorization of emergency use to treat the coronavirus, said the former head of the United States Food and Drug Administration.

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

Gottlieb said the United States government could encourage drug makers to cut production of less essential drugs for a time, in favor of doing more antibody treatments now.

A handful of drug manufacturers and academic centers are competing to test new antibody treatments for 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 immune responses to the virus, and may report some of the first results in the third trimester.

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

Read more: Antibody treatments may be the best hope against the virus until the vaccine

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

As it stands, the US may have enough Gilead medication 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 becoming seriously ill, EE The window and I 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 United States continues to record a record number of daily cases.

“We are not going to be able to crush this virus right now because there is so much infection around, and it really doesn’t seem like we have the political will to do it,” he said.

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