FDAnews
www.fdanews.com/articles/196863-sanofi-regeneron-modify-kevzara-trial-after-preliminary-results-fall-short

Sanofi, Regeneron Modify Kevzara Trial After Preliminary Results Fall Short

April 28, 2020

Sanofi and Regeneron have modified their clinical trial of the rheumatoid arthritis drug Kevzara (sarilumab) as a COVID-19 treatment after preliminary results found no benefit in one group.

The trial has been amended to include only patients requiring mechanical ventilation, high-flow oxygen or treatment in an intensive care unit. The patients will be given either a higher dose of Kevzara (400 mg) or a placebo.

Preliminary analysis of phase 2 data identified negative trends for most outcomes in the severe group, but positive trends for all outcomes in the critical group.

In the critical group, fewer patients died and needed ventilators when taking low (200 mg) or high (400mg) doses of Kevzara compared to a placebo. More patients given Kevzara also showed improvement and were discharged.

The phase 3 portion of the trial will focus on critical patients that are taking either a high dose of the arthritis drug or a placebo. There are currently 600 critical patients enrolled, and results are expected by June. — Jordan Williams