Incyte: Phase 3 Results for Ruxolitinib (Jakafi®) in Ventilator Covid Patients Not Significant

 - Improvement in mortality for each dose compared to placebo, while trending toward positive, was not statistically significant for the overall study population

- Significant improvement in mortality seen in U.S. study participants at both doses, and in the overall population when data from both treatment arms was pooled

- Expanded Access Program to allow eligible patients in the United States with COVID-19 associated ARDS to receive ruxolitinib will be discussed with the U.S. Food and Drug Administration

Given the urgent nature of the COVID-19 pandemic, Incyte plans to make ruxolitinib available to eligible patients in the United States at no cost via an Expanded Access Program (EAP) pending agreement with the U.S. Food and Drug Administration. The protocol will allow eligible patients with severe COVID-19 associated ARDS with disease severity requiring mechanical ventilation to receive ruxolitinib.

At present, there is ample commercial and clinical supply of ruxolitinib in the United States to meet the needs of U.S. patients receiving ruxolitinib in its approved indications and those participating in clinical trials or the COVID-19 EAP.

For more information about Incyte’s response to COVID-19, including information on the DEVENT study and EAP, visit: Incyte.com/COVID-19.

https://www.businesswire.com/news/home/20210318005781/en/Incyte-Announces-Results-from-the-Phase-3-DEVENT-Study-Evaluating-Ruxolitinib-Jakafi%C2%AE-as-a-Treatment-for-Patients-with-COVID-19-Associated-Acute-Respiratory-Distress-Syndrome-ARDS-on-Mechanical-Ventilation