FDA Clears Novartis to Open Hydroxychloroquine Trial for COVID-19
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Novartis has reached an agreement with the FDA clearing the way for the company to sponsor a large clinical trial studying the use of hydroxychloroquine among hospitalized patients with COVID-19, according to a press release.
The phase 3 trial will recruit approximately 440 participants across more than a dozen sites in the United States, with enrollment scheduled to begin in the next few weeks, the company said. The drug supply will be provided by Sandoz, the generics and biosimilars division of Novartis.
“We recognize the importance of answering the scientific question of whether hydroxychloroquine will be beneficial for patients with COVID-19 disease,” John Tsai, MD, chief medical officer and head of global drug development at Novartis, said in the release. “We mobilized quickly to address this question in a randomized, double-blind, placebo-controlled study.”
Novartis also announced it will make available, through non-exclusive voluntary licenses or similar mechanisms, any intellectual property within its control that relates to the use of hydroxychloroquine to treat or prevent COVID-19. According to the company, their aim is to “help achieve broad access to hydroxychloroquine as quickly as possible in these extraordinary circumstances.”
Since President Donald Trump press conference last month in which he touted the drug’s still-unproven benefits in COVID-19, there have been reported shortages of hydroxychloroquine across the United States, impacting patients with rheumatoid arthritis or lupus who have long relied on the treatment. Both hydroxychloroquine sulfate and chloroquine phosphate tablets have been listed on the FDA’s drug shortages website since March 31.
Asked for comment, Alfred H.J. Kim, MD, PhD, of the Washington University School of Medicine, in St. Louis, Missouri, applauded the expanding effort to test the use of hydroxychloroquine in patients with COVID-19. However, he added that the overuse of the drug as a preventative measure, despite the absolute lack of evidence for its impact as a prophylactic, continues to be a concern.
“I am happy to see more stakeholders such as Novartis/Sandoz involved in examining the utility of hydroxychloroquine in treating COVID-19,” Kim told Healio Rheumatology. “The likelihood of this clinical trial impacting overall hydroxychloroquine supplies will likely be minimal, as the total number of eligible patients is small, at 440 total patients. I am still very concerned about the overutilization of hydroxychloroquine for the prevention of COVID-19. This dramatically increases the number of potential patients taking hydroxychloroquine, which is currently still unjustified due to the absence of data.”
There are currently more than 100 clinical trials set to study the use of hydroxychloroquine among patients with COVID-19 listed by the NIH U.S. Library of Medicine at clinicaltrials.gov. All but one of them are either still recruiting, not yet recruiting or enrolling by invitation.
Those recruited into the Novartis trial will be randomly assigned into one of three groups, one of which will receive hydroxychloroquine while another will be treated with hydroxychloroquine in combination with the antibiotic azithromycin. The third group will receive placebo. All participants are receiving standard of care for COVID-19, the company said.
“It’s vital that the efficacy of hydroxychloroquine be studied in well-controlled randomized trials – this is the only way that we are going to find out whether or not it actually works,” G. Caleb Alexander, MD, MS, of the Johns Hopkins Bloomberg School of Public Health Center for Drug Safety and Effectiveness, told Healio Rheumatology. “Perhaps as important as Novartis’ announcement of the trial is their commitment — if the drug works — to make intellectual property available so as to support broad access.”
“This is important because, if anecdotal evidence of the product’s value against COVID-19 is confirmed in well-controlled randomized trials, there is going to be an enormous surge in demand for the product, far surpassing what we have seen so far,” he added. “Hydroxychloroquine is just one of dozens of therapeutic agents under investigation to treat COVID-19, and the pandemic has unleashed an enormous wave of scientific activity focused on finding successful treatments.”
According to Novartis, the clinical trial “compliments” the company’s commitment, through Sandoz, to donate up to 130 million tablets of hydroxychloroquine to supply global clinical research efforts in the event the drug is proven beneficial in COVID-19. Sandoz has so far donated 30 million tablets to HHS, and is dispatching additional shipments to countries based on requests from governments, according to the press release.
“We are donating hydroxychloroquine tablets for COVID-19 patients including for use in this and other clinical trials with the hope that researchers and health care workers can quickly and scientifically determine whether hydroxychloroquine can help patients around the world combat this disease,” Richard Saynor, PharmB, CEO of Sandoz, said in the release. “We will continue to fulfill orders for existing customers to ensure the medicine remains available to U.S. patients who rely on it for other indicated uses.” —by Jason Laday