Novartis Beginning Phase 3 Of Clinical Trial In Trump-Touted Drug, Hydroxychloroquine, For Coronavirus Patients
The Food and Drug Administration (FDA) and the Switzerland-based pharmaceutical company, Novartis, have reached an agreement allowing the company to conduct a clinical trial of hydroxychloroquine for patients with the novel coronavirus.
Hydroxychloroquine has been touted by President Donald Trump and others as a potential cure for the virus, despite having only anecdotal evidence to back their opinions. Experts largely agreed that a large-scale, controlled clinical trial would be necessary for determining its efficiency in treating coronavirus.
Novartis announced on Monday that the study will be conducted in over a dozen U.S. labs and that enrollment for phase three of the trial will begin in the next few weeks.
The trial will examine the anti-malarial drug’s effects on about 440 patients, Novartis said, adding that the drug supply would be provided by Sandoz, the company’s generics and biosimilars division.
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Last month, the FDA issued an emergency use authorization for hydroxychloroquine in treating coronavirus, but spotlighting the drug in the media has caused difficulties for patients already prescribed the drug to treat autoimmune diseases to find it in stock.
“We are concerned that increased demand for these drugs attributed to COVID-19 has exacerbated their already limited availability for patients who rely on them to meet their medical needs,” the American College of Rheumatology, American Academy of Dermatology, Arthritis Foundation and Lupus Foundation of America wrote in a joint statement to Vice President Mike Pence. “Therefore, we urge you to work with us and the broader health care community to help ensure continued availability of these drugs for the patients who are maintained on them to avoid disability, illness and even early death.”
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