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Novartis announces plan to initiate clinical study of Jakavi® in severe COVID-19 patients and establish international compassionate use program

Novartis announces plan to initiate clinical study of Jakavi® in severe COVID-19 patients and establish international compassionate use program

Novartis has announced plans to initiate a Phase III clinical trial in collaboration with Incyte to evaluate the use of Jakavi® (ruxolitinib) for treatment of a type of severe immune overreaction called cytokine storm that can lead to life-threatening respiratory complications in patients with COVID-191-3.

The decision is based on pre-clinical evidence and preliminary reports from independent studies, and is supported by extensive data on the safety and efficacy of Jakavi in conditions like acute graft versus host disease and myeloproliferative neoplasms. The proposed trial will assess Jakavi in combination with standard of care (SoC) therapy, compared to SoC therapy alone, in patients with severe COVID-19 pneumonia as a result of SARS-CoV-2 infection.

“Novartis is taking a number of steps to address the urgent needs arising from the COVID-19 pandemic, including the evaluation of our existing therapies to assess if any can be utilized beyond their approved indications,” said John Tsai, Head Global Drug Development and Chief Medical Officer, Novartis. “The potential that Jakavi could lead to faster recovery times for COVID-19 patients with fewer requiring intensive care and mechanical ventilation is encouraging and absolutely merits further investigation. We now are moving rapidly to finalize the study plan and then to enroll eligible patients, as well as put in place a process to provide access for patients unable to participate in the trial.”

Given the rapid spread of the pandemic, and as plans for the study are finalized, Novartis also has set up an international compassionate use program for eligible patients, subject to local regulations. In addition, we are taking steps to manage the anticipated increase in COVID-19 related requests for Jakavi without interrupting access for patients taking the drug for its licensed indications. In the US, ruxolitinib access requests are coordinated by Incyte.

Novartis commitment and response to COVID-19
Novartis is deeply dedicated to the global effort to combat COVID-19 and doing our part to support the stability of global healthcare systems. We announced a broad set of measures including the creation of a global fund of USD 20 million to support communities around the world impacted by the COVID-19 pandemic. Novartis also has committed 130 million doses of hydroxychloroquine to support pandemic response. In addition, Novartis joined two key cross-industry research initiatives, the COVID-19 Therapeutics Accelerator, coordinated by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard, as well as a COVID-19 directed partnership organized by the Innovative Medicines Initiative (IMI). Novartis is separately supporting COVID-19 related clinical investigations of several Novartis medicines. To support access, the Novartis generics and biosimilars division Sandoz became the first company to commit to keeping stable prices for a basket of essential medicines that may help in the treatment of COVID-19. More information about the Novartis response to COVID-19 is available on Novartis.com/coronavirus.