- Novartis AG (NYSE:NVS) has received clearance from the U.S. Food and Drug Administration to launch a randomized trial of malaria drug hydroxychloroquine against COVID-19
Novartis AG (NYSE:NVS) has received clearance from the U.S. Food and Drug Administration to launch a randomized trial of malaria drug hydroxychloroquine against the COVID-19 disease in order to see if it helps patients.
The medication — which is decades-old — had received FDA emergency use authorization this month for the unapproved use for coronavirus disease. Currently, there is no scientific proof that it works. And there are no approved COVID-19 medicines yet.
Novartis is planning to start recruiting 440 patients for its Phase III (late-stage trial) within weeks at over a dozen U.S. sites. And the results will be reported as soon as possible.
The use of the drug (also approved to treat lupus and rheumatoid arthritis) has surged after it was promoted by President Donald Trump.
“We recognize the importance of answering the scientific question of whether hydroxychloroquine will be beneficial for patients with COVID-19 disease,” said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer at Novartis via CNBC. “We mobilized quickly to address this question in a randomized, double-blind, placebo-controlled study.”
The University of Washington, the University of Minnesota, and the National Institutes of Health in the U.S. are also conducting studies of hydroxychloroquine. And
