Novartis has won the green-light from the U.S. FDA to conduct a randomized trial of malaria drug hydroxychloroquine against COVID-19 disease, the Swiss drug producer stated Monday, to see if it helps patients.
The decades-old generic drugs got FDA emergency use authorization this month for its unapproved use for coronavirus disease; however, so far, there is no scientific proof it really works.
Novartis plans to start recruiting 440 sufferers for its Phase III, or late-stage trial inside weeks at over a dozen U.S. websites. Results can be reported as soon as doable, the corporate added.
The use of the drug, further authorized 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 quick-circuited the FDA’s oversight course.
Firms such as Novartis, Roche, and Gilead Sciences are testing older medicines developed to deal with other ailments, for signs, they may very well be repurposed to tackle the coronavirus epidemic. Gilead just expanded a trial of its Ebola drug remdesivir.
Still, some fear the championing of hydroxychloroquine by Trump and others as a possible “sport changer” in opposition to COVID-19 has overshadowed harmful unintended effects like vision loss and heart issues. Novartis CEO Vas Narasimhan has also stated the drugs is one of his largest hopes against the viral epidemic.
There are several further studies of hydroxychloroquine underway, including on the College of Washington and College of Minnesota, in addition to work by the National Institutes of Health in the U.S.