Eli Lilly (LLY) on Wednesday applied to the U..S. Food and Drug Administration (FDA) for an emergency use authorization of its COVID-19 treatment drug, as President Donald Trump’s recovery highlights the growing use of therapeutics in combating the virus.
In the wake of Trump’s release from Walter Reed Military Medical Center earlier this week — where he received a dose of Regeneron’s (REGN) experimental cocktail, among others — potential antibody treatments are now sharing the spotlight with vaccines.
Pharmaceutical giant Lilly recently released data showing its monoclonal antibody treatment was effective in mild to moderate COVID-19 patients, forming the basis of its narrowly-defined emergency use filing. The company anticipates being able to supply 100,000 doses in October, and one million doses by the end of the year.
In addition, the company is looking to apply next month for an EUA for a combination treatment of two antibody treatments in November. The current EUA would be used to treat “higher-risk patients who have been recently diagnosed with mild-to-moderate COVID-19.”
Doctors and bioethicists, such as New York University Langone professor Dr. Arthur Caplan, said that vaccine companies are also likely to pursue such narrow filings.
Past examples include an anthrax treatment filing back in 2005 and most recently, EUAs for Gilead’s antiviral drug, convalescent plasma and hydroxychloroquine, which has since been revoked. All were approved for hospitalized patients only, with specific criteria to be met.
Similarly, vaccine companies can choose only health workers or high-risk populations, or even certain age groups, for EUA requests. According to experts, it would serve as a guardrail for companies racing to the finish line this month.
Even still, questions remain about the impact of the treatment Trump received, a mix of experimental and proven drugs. The president received the final dose of Gilead Science’s (GILD) antiviral remdesivir Tuesday — the only authorized treatment — but analysts expect Regeneron’s antibody treatment to receive emergency use authorization soon.
Trump upset with ‘political hit job’
Amid a raging debate over the timeline to approve a COVID-19 cure, a pre-Election Day deadline now appears definitively off the table. On Tuesday, the White House approving new guidelines from the FDA that would require two months of follow-up on late-stage clinical trial participants. The previous guidelines were for one month.
The surprise move was more in line with what scientists seek to help boost public trust in the approval process, and quell doubts about political pressure. However, the decision has riled Trump, who called out his FDA Commissioner, Stephen Hahn, in a tweet late Tuesday.
New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job! @SteveFDA
— Donald J. Trump (@realDonaldTrump) October 7, 2020
Another agency suffering from increased public mistrust is the U.S. Centers for Disease Control and Prevention (CDC). A former CDC director penned a letter to current Director Dr. Robert Redfield, asking him to push back against political pressure.
William Foege — credited with devising the strategy that eradicated smallpox in the U.S. — wrote in a letter published by USA Today the politicized response to COVID-19 “will go down as a colossal failure of the public health system of this country.” Foege urged Redfield to salvage the agency’s reputation, which he said has gone from “gold to tarnished brass.”
The scathing letter highlights the dire situation both the CDC and FDA have found themselves in, with reports over the past several months highlighting the depth of interference from the Trump White House.
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