Novartis provides update on RUXCOVID study of ruxolitinib for hospitalized patie

Novartis today announced that the Phase III RUXCOVID study evaluating ruxolitinib on top of standard of care (SoC) therapy compared to SoC treatment alone in patients with COVID-19 did not meet its primary endpoint.

"While the RUXCOVID trial did not give us the results we hoped for, we will continue working with the medical community to analyze its findings to better understand COVID-19 and the role of JAK inhibition," said John Tsai, Head Global Drug Development and Chief Medical Officer, Novartis. "We would like to thank the front-line clinical teams and staff at each of the trial sites and the hundreds of patients who volunteered to participate and their loved ones. We are deeply grateful to them and will continue our dedicated scientific research into the ongoing global pandemic."

In the trial, the proportion of patients who died, or required mechanical ventilation due to respiratory failure or ICU care by Day 29, the primary endpoint, was 12.0% for ruxolitinib plus SoC vs. 11.8% for placebo plus SoC (OR: 0.91 [95% CI: 0.48-1.73]; p=0.769)1. Ruxolitinib was generally well-tolerated, and a comprehensive analysis including safety data is ongoing1. The results of RUXCOVID do not affect any ongoing trials for ruxolitinib in non-COVID-19 diseases.