- The P-III RUXCOVID study involves assessing of ruxolitinib (5mg, bid) + SoC vs PBO + SoC in 400 patients in a ratio (2:1) aged ≥12 yrs. with COVID-19 associated cytokine storm. The study is sponsored by the Incyte in the US and Novartis outside the US
- The composite 1EP is the proportion of patients who die, develop respiratory failure (require mechanical ventilation) or require ICU care by day 29. The 2EPs includes evaluation of clinical status using a 9-point ordinal scale, in-hospital outcomes, change in the NEWS2, change in SpO2/FiO2 ratio, proportion of patients with no oxygen therapy and safety
- Additionally, Incyte is initiating an emergency EAP in the US, allowing patients to receive ruxolitinib while it is being investigated. Jakafi is a first-in-class JAK1/JAK2 inhibitor, approved by the US FDA for PV in adults who have had an inadequate response to hydroxyurea, in adults with intermediate/high-risk MF, including primary MF, post-polycythemia vera MF, post-essential thrombocythemia MF and for steroid-refractory acute GVHD in adult and pediatric patients aged ≥12 yrs.
Click here to read full press release/ article | Ref: Incyte | Image: Technical.ly