REFILE-UPDATE 1-Novartis, U.S. drug regulator agree to malaria drug trial against COVID-19 [Reuters]
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Source: Reuters
Novartis, U.S. drug regulator agree to malaria drug trial against COVID-19 ZURICH (Reuters) - Novartis ( NOVN.S ) has won the go-ahead from the U.S. Food and Drug Administration to conduct a randomized trial of malaria drug hydroxychloroquine against COVID-19 disease, the Swiss drugmaker said on Monday, to see if it helps patients. The decades-old generic medicine got FDA emergency use authorization this month for its unapproved use for coronavirus disease, but so far there is no scientific proof it works. There are currently no approved COVID-19 medicines. Novartis plans to start recruiting 440 patients for its Phase III, or late-stage, trial within weeks at more than a dozen U.S. sites. Results will be reported as soon as possible, the company added. Use of the drug, also approved to treat lupus and rheumatoid arthritis, has soared after having been promoted by President Donald Trump, with some worried the administration’s advocacy for an unproven medicine for COVID-19 has short-c
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