Incyte reported disappointing results in using its blockbuster drug Jakafi (ruxolitinib) in treating the severest cases of Covid-19.
However, the company based near Wilmington will seek to make the drug available as an option for Covid patients on ventilators.
In trials, the drug was used on mechanical ventilation patients with Covid-19 associated Acute Respiratory Distress Syndrome, a respiratory failure characterized by rapid and widespread inflammation in the lungs.
While results indicate a trend towards an improvement in mortality in the overall study population, the DEVENT study did not meet its primary endpoint. The U.S. study population, which accounts for 91 percent of the study patients, did show an improvement in mortality.
An analysis of the overall study population pooling of two different ruxolitinib doses showed a statistically significant improvement in mortality.
“There remains a significant unmet medical need for treatments that may potentially improve survival outcomes for patients suffering from severe Covid-19 related complications, specifically those requiring mechanical ventilation,” said Steven Stein, M.D., chief medical officer, Incyte. “We hope the results of this study, and the potential utility of ruxolitinib for the treatment of patients with severe Covid-19 associated ARDS, will contribute to the advances being made across the scientific community to alleviate the burden this pandemic has placed on patients, as well as the healthcare system. We look forward to discussing the results of the DEVENT study with regulatory authorities in the United States.”
Incyte plans to make ruxolitinib available to eligible patients in the United States at no cost via an Expanded Access Program, pending an 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.
