Press release
Incyte Announces Plans to Initiate a Phase 3 Clinical Trial of Ruxolitinib (Jakafi®) as a Treatment for Patients with COVID-19 Associated Cytokine Storm
- Incyte also intends to launch an Expanded Access Program in the United States to allow eligible patients with COVID-19 associated cytokine storm to receive
About this update from Incyte Corporation
[{"type":"text","content":"\n- Incyte also intends to launch an Expanded Access Program in the United States to allow eligible patients with COVID-19 associated cytokine storm to receive ruxolitinib\n\n\n- Incyte has an ample commercial and clinical supply of ruxolitinib in the U.S. and is increasing manufacturing efforts in response to the COVID-19 pandemic\n\n WILMINGTON, Del.--(BUSINESS WIRE)--\nIncyte (Nasdaq:INCY) today announced the Company is working with the U.S. Food and Drug Administration (FDA) to initiate a Phase 3 clinical trial (RUXCOVID) to evaluate the efficacy and safety of ruxolitinib (Jakafi®) plus standard-of-care (SoC), compared to SoC therapy alone, in patients with COVID-19 associated cytokine storm. The collaborative study will be sponsored by Incyte in the United States and Novartis outside of the United States.\n\n\nAdditionally, given the urgent nature of the COVID-19 pandemic, Incyte intends to initiate a separate open-label emergency Expanded Access Program (EAP) in the United States. The protocol will allow eligible patients with severe COVID-19 associated cytokine storm to receive ruxolitinib while it is being investigated for this indication.\n\n\n“Our intent is to build on emerging evidence from independent studies to further establish the role ruxolitinib could play in balancing immune response to the infection and therefore potentially improving outcomes of patients with COVID-19 associated cytokine storm,” said Steven Stein, M.D., Chief Medical Officer, Incyte. “We recognize the significant and urgent medical need of patients with severe COVID-19 infection, and we are working with the FDA in an effort to rapidly advance the RUXCOVID and EAP studies.”\n\n\nIn the interim, as the Phase 3 study and EAP protocols are awaiting potential approval by the FDA, questions or inquiries regarding the availability of ruxolitinib for compassionate use or independent research should be made to:\n\n\nU.S. Medical Information\n1-855-4MED-INFO (1-855-463-3463)\[email protected].\n\n\nRuxolitinib is a Janus kinase (JAK1/JAK2) inhibitor discovered by Incyte scientists. Overactive signaling through the JAK-STAT pathway has been associated with many types of cancer, including a group of rare blood cancers called myeloproliferative neoplasms (MPNs), as well as other serious immune-mediated conditions such as graft-versus-host disease (GVHD)...