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

• New clinical trial to evaluate Jakavi (ruxolitinib) in patients with COVID-19 associated cytokine storm
   
• Cytokine storm is a type of severe immune overreaction that can result from coronavirus infection and may contribute to respiratory compromise in patients with COVID-19^1-3
  
  
• Pre-clinical and preliminary clinical evidence suggests Jakavi, a well-established JAK inhibitor, could reduce the number of patients requiring intensive care and mechanical ventilation
  
  
• Novartis to establish compassionate use program for COVID-19 patient access and undertake steps to ensure uninterrupted supply of Jakavi for currently licensed indications

Basel, April 2, 2020 — Novartis today 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-19^1-3.

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.”