Amid Regeneron's emergency use bid, former FDA chief says U.S. 'too late' on mass manufacture of COVID-19 antibodies

Days removed from its star turn in President Donald Trump's COVID-19 treatment, Regeneron's antibody cocktail could be on the fast track to an emergency approval. But if it gets there, will there be enough supply to meet this year's demand? That boat's already sailed, a former FDA chief warned.

As Regeneron pursues an emergency use authorization for the cocktail, drugmakers are already "too late" scaling up manufacturing to produce enough antibody doses to meet demand this year, former FDA Commissioner Scott Gottlieb, M.D., said Sunday.

On CBS' Face the Nation, Gottlieb forecast the U.S. would need to produce between 300,000 and 400,000 antibody treatment courses each month to keep up with continued demand in what he called a potentially "difficult fall and winter."

In an earlier segment on the show, Regeneron CEO Len Schleifer noted the company only has around 50,000 treatment courses stocked but is working toward supplying 300,000 courses to the U.S. within the next few months as part of a $450 million contract signed in July.

"We would have needed to take different steps in April and May to ramp up manufacturing capacity to have the drug available in larger quantities now," Gottlieb said. "It's too late for this year. I think we could still take steps to do it for 2021, but we're stuck with the doses we have." 

Regeneron's cocktail, dubbed REGN-COV-2, saw rising interest after Trump received the therapy during his COVID-19 treatment earlier this month. Regeneron late last week filed for an emergency use authorization for the cocktail—which Trump called a "cure"—despite limited late-stage data supporting its use in COVID-19 patients.

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