Novartis gets FDA approval for Phase III trial of hydroxychloroquine for COVID-19

Novartis is proceeding with a Phase III clinical trial to evaluate the use of hydroxychloroquine for the treatment of patients with COVID-19 disease.

The company got the go-ahead from the US Food and Drug Administration (FDA). The trial will involve approximately 440 patients and be conducted at more than a dozen sites in the United States. The clinical trial drug supply will be provided by Sandoz, the generics and biosimilars division of Novartis.

Novartis will begin enrollment for this study within the next few weeks.

“We recognize the importance of answering the scientific question of whether hydroxychloroquine will be beneficial for patients with COVID-19 disease,” John Tsai, head of global drug development and chief medical officer at Novartis, said. “We mobilized quickly to address this question in a randomized, double-blind, placebo-controlled study.”

Patients in the trial will be randomized into three groups with one group receiving hydroxychloroquine, another group receiving hydroxychloroquine in combination with azithromycin, and a third group receiving a placebo.

“We are donating hydroxychloroquine tablets for COVID-19 patients including for use in this and other clinical trials with the hope that researchers and healthcare workers can quickly and scientifically determine whether hydroxychloroquine can help patients around the world combat this disease,” Richard Saynor, CEO of Sandoz, said. “We will continue to fulfill orders for existing customers to ensure the medicine remains available to US patients who rely on it for other indicated uses.”

Hydroxychloroquine has garnered interest in the medical community after showing preliminary promise in small clinical studies, including one with co-administration with the antibiotic azithromycin. Also, hydroxychloroquine has demonstrated antiviral activity against SARS-CoV-2 in laboratory tests. The drug has long been used for the treatment of malaria and certain autoimmune diseases.