The US Food and Drug Administration (FDA) has authorised Novartis to proceed with a Phase III trial of hydroxychloroquine in 440 patients in the US hospitalised with Covid-19.
There has been significant hype around this anti-malarial drug as a treatment for Covid-19, mainly as a result of US President Trump’s support for the drug and small scale studies suggesting it may be efficacious against the novel coronavirus.
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Sandoz, Novartis’ generics division, will provide the drug doses needed for the clinical study. The company has committed 130 million tablets of hydroxychloroquine to support clinical efforts against Covid-19, with 30 million already supplied to the US Department of Health and Human Services.
Novartis chief medical officer and head of global drug development John Tsai said: “We recognise the importance of answering the scientific question of whether hydroxychloroquine will be beneficial for patients with Covid-19 disease.
“We mobilised quickly to address this question in a randomised, double-blind, placebo-controlled study.”
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