What took so long?
OH!….That’s right!….FDA!….My Bad!
Switzerland-based pharmaceutical firm Novartis says it will be conducting a clinical trial of antimalarial drug hydroxychloroquine on U.S. hospital patients with COVID-19.
The company confirmed today an agreement had been struck with the Food and Drug Administration (FDA) to proceed with a trial on more than 400 infected patients—hoping to evaluate the effectiveness of the drug once described as a potential “game-changer” by President Donald Trump.
There is no cure for the infectious respiratory disease, caused by a novel coronavirus that was first detected in China last year, according to the Centers for Disease Control and Prevention.
But in recent weeks, clinical tests have been taking place around the world in an attempt to determine if hydroxychloroquine could ease some of its symptoms—with largely mixed results.
In White House briefings and on Twitter, the president has promoted the drug as a potential treatment and earlier confirmed the U.S. had stockpiled 29 million pills, despite its use being unproven.
Novartis has said its upcoming clinical trial will take place at “more than a dozen sites” in the country and plans to begin enrollment for the study within the next few weeks. The trial’s drug supply will be provided by Sandoz, the generics and biosimilars arm of the company.
The patients in the trial will be randomized into three groups, with the first group administered with hydroxychloroquine. The second group will receive hydroxychloroquine in combination with azithromycin, an antibiotic therapy. The third patient group will receive placebo medicine.
Those in the trial will continue to receive standard COVID-19 hospital treatment. Novartis said months of work had been compressed into weeks, and noted any intellectual property proven to work will be made available via non-exclusive voluntary licenses and “appropriate waivers.”
“We recognize the importance of answering the scientific question of whether hydroxychloroquine will be beneficial for patients with COVID-19 disease……..We mobilized quickly to address this question in a randomized… placebo-controlled study.”
John Tsai
Novartis’ Chief Medical Officer
In addition to hydroxychloroquine, Novartis said it plans to sponsor or co-sponsor clinical trials to study ruxolitinib and canakinumab for hospitalized patients who have contracted COVID-19.
On April 3, the FDA authorized the emergency use of hydroxychloroquine from the Strategic National Stockpile to treat patients hospitalized with the illness. But it warned of a wide range of potential side effects and stressed that the optimal dosing and duration of treatment remained unknown.
Novartis Reaches Agreement with FDA: Sponsors Clinical Trial of Hydroxychloroquine
Calamity Jane