COVID-19 Daily Briefing 4/3
April 2, 9 pm.
April 2, 9 p.m.
Incyte to begin a Phase 3 clinical trial of Ruxolitinib (Jakafi®) as treatment for COVID-19
Incyte announced the Company is working with the 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.
Incyte alsointends 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.
“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 at Incyte, said in a statement. “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.”