COVID-19 therapeutic data for emergency use could be months away

COVID-19 therapeutic data for emergency use could be months away

HHS Secretary Alex Azar on Friday said that data that could allow for emergency authorization of experimental COVID-19 therapeutics could be available in a matter of weeks. Azar made the comments during a congressional hearing conducted by the House Select Subcommittee on the Coronavirus Crisis when Rep. Blaine Luetkemeyer (R-Mo.) asked about promising preliminary results from trials on an experimental Regeneron drug that is being developed to treat less severe cases of COVID-19.”We could be literally many weeks to a month or two away from having data to support emergency authorizations of these if the data proves they are safe as well as effective,” Azar said. Luetkemeyer said he was trying to highlight that there are also therapeutics in the drug development pipeline, not just vaccines. Early data showed that Regeneron’s antibody cocktail, dubbed REGN-COV2, appeared to reduce the time it took for patients’ symptoms to alleviate compared with trial participants who received placebos. The Regeneron drug and a competing Eli Lilly drug are combinations of monoclonal antibodies, meaning that the drugs are supposed to act as synthetic substitutes for antibodies. Eli Lilly’s Phase 2 trials on LY-CoV555, which showed mixed results, were conducted on nonhospitalized patients.Azar’s testimony came just hours after President Donald Trump announced he had tested positive for COVID-19. Trump’s doctor on Friday said the president received a dose of Regeneron’s antibody cocktail. Trump has often touted the accelerated timeline for vaccine approval on the campaign trail. In the first presidential debate Tuesday, he teased that a COVID-19 vaccine could be “weeks away,” and contradicted the opinions of some of his top public health experts who have projected vaccines will be widely available by mid-2021.

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