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.
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.”