Novartis 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 land drugmaker said on Monday, to determine if it helps patients.
The decades-old generic medicine got FDA emergency use authorization this month for its unapproved use for coronavirus disease, but to date, there’s no scientific proof it works. There are currently no approved COVID-19 medicines.
Novartis plans to start out recruiting 440 patients for its clinical test, or late-stage, a trial within weeks at over a dozen U.S. sites. Results are reported as soon as possible, the corporate added.
Use of the drug, also approved to treat lupus and 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-circuited the FDA’s oversight process.
“We recognize the importance of answering the scientific question of whether hydroxychloroquine is beneficial for patients with COVID-19 disease,” said John Tsai, Novartis’s top drug developer. “We mobilized quickly to deal with this question in a very randomized, double-blind, placebo-controlled study.”
Companies like Novartis, Roche and Gilead Sciences are testing older medicines developed to treat other diseases, for signs they may be repurposed to tackle the coronavirus epidemic. Gilead just expanded a shot of its Ebola drug redeliver.
Still, some fear the championing of hydroxychloroquine by Trump et al. as a possible “game-changer” against COVID-19 has overshadowed dangerous side effects like vision loss and heart problems. Novartis CEO Vas Narasimhan has also said the drugs is one in every of his biggest hopes against the viral epidemic.
There are several additional studies of hydroxychloroquine underway, including at the University of Washington and the University of Minnesota, likewise as work by the National Institutes of Health within the US.
Novartis’s Sandoz generics unit has pledged to donate 130 million doses of the drugs to be used. Sanofi has also said it’ll donate 100 million doses of hydroxychloroquine to 50 countries.