FDA approves Novartis' trial of hydroxychloroquine in hospitalized COVID-19 patients

The US Food and Drug Administration has agreed that Swiss pharma giant (NOVN: VX) can proceed with a Phase III clinical trial with around 440 patients to evaluate the use of hydroxychloroquine for the treatment of hospitalized patients with 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, whose shares were up 1.3% at 87.11 Swiss francs by late morning trading.

The large trial sponsored by Novartis will be conducted at more than a dozen sites in the USA. Novartis plans to begin enrollment for this study within the next few weeks and is committed to reporting results as soon as possible. To help achieve broad access to hydroxychloroquine as quickly as possible in these extraordinary circumstances, Novartis says it will make any intellectual property within its control that relates to the use of hydroxychloroquine to treat or prevent COVID-19 available through non-exclusive voluntary licenses, appropriate waivers, or similar mechanisms.