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Novartis, U.S. drug regulator agree to malaria drug trial against COVID-19

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 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-circuited the FDA’s oversight process.

“We recognize the importance of answering the scientific question of whether hydroxychloroquine will be beneficial for patients with COVID-19 disease,” said John Tsai, Novartis’s top drug developer. “We mobilized quickly to address this question in a randomized, double-blind, placebo-controlled study.”

Companies such as Novartis, Roche and Gilead Sciences are testing older medicines developed to treat other diseases, for signs they could be repurposed to tackle the coronavirus epidemic. Gilead just expanded a trial of its Ebola drug remdesivir.

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Meeta Ramnani
Meeta Ramnani
Meeta develops credible content about various markets based on deep research, opinions from experts and inputs from industry leaders. As the managing editor at Smart Industry News, she assures that every piece of news and article adds to the knowledge of decision makers. An avid bike rider, Meeta, is a postgraduate from Indian Institute of Journalism and New Media (IIJNM) Bangalore, where her specialization was Business Journalism. She carries experience from mainstream print media including The Times Group and Sakal Media Group.
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