Basel: Swiss multinational pharmaceutical company Novartis has reached an agreement with the US Food and Drug Administration (FDA) to proceed with a phase three clinical trial with about 440 patients to evaluate the use of hydroxychloroquine for the treatment of hospitalised patients with COVID-19 disease.
The clinical trial drug supply will be provided by Sandoz, the generics and biosimilars division of Novartis.
The large trial sponsored by Novartis will be conducted at more than a dozen sites in the United States. Novartis plans to begin enrollment for this study within the next few weeks and is committed to reporting results as soon as possible, it said in a statement.
To help achieve broad access to hydroxychloroquine as quickly as possible in today’s extraordinary circumstances, Novartis 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.
“We recognise the importance of answering the scientific question of whether hydroxychloroquine will be beneficial for patients with COVID-19 disease,” said John Tsai, Head of Global Drug Development and Chief Medical Officer at Novartis. “We mobilised quickly to address this question in a randomised, double-blind, placebo-controlled study.”
As the new virus continues to spread and claim lives around the globe, doctors and patients are eager for treatment options. In some cases, clinicians are evaluating drugs that have been approved for other diseases, hoping that these will also work against COVID-19.
The clinical trial complements a commitment by Novartis through Sandoz to donate up to 130 million tablets of hydroxychloroquine to supply global clinical research efforts in the event the medicine is proven beneficial for the treatment of COVID-19.
