FDA approves Novartis to begin phase III clinical trial of hydroxychloroquine in 440 hospitalized coronavirus patients

The US Food and Drug Administration (FDA) has agreed that Swiss pharma giant tot proceed with a Phase III clinical trial with around 440 patients to evaluate the use of malaria drug hydroxychloroquine for the treatment of hospitalized patients with coronavirus COVID-19 disease.

The clinical trial drug supply of hydroxychloroquine, a decades-old generic medicine, will be provided by Sandoz, the generics and biosimilars division of Novartis. Hydroxychloroquine has become the most controversial drug after President Trump touted the drug on social media as a potential game-changer. Many doctors and patients have also  credited hydroxychloroquine for saving their lives since the drug was first tested by renowned French Professor Didier Raoult in March.

Last month, we told you after Novartis CEO said malaria drug hydroxychloroquine is biggest hope against coronavirus. “We recognize the importance of answering the scientific question of whether hydroxychloroquine will be beneficial for patients with COVID-19 disease,” said John Tsai, head of global drug development and chief medical officer at Novartis, adding: “We mobilized quickly to address this question in a randomized, double-blind, placebo-controlled study.”

In addition to hydroxychloroquine, Novartis said it also plans to sponsor or co-sponsor clinical trials to study ruxolitinib and canakinumab for hospitalized patients with COVID-19 infections.

In the meantime, Bayer and Teva agreed to donate hydroxychloroquine or similar drugs, while Gilead Sciences is testing its experimental drug remdesivir against coronavirus. Novartis International AG is a Swiss multinational pharmaceutical company based in Basel, Switzerland. The Sandoz brand is a division of the Novartis Group and a global leader in generic pharmaceuticals and biosimilars.