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.
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.
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.