Roche says REMDACTA trial misses in severe COVID-19 pneumonia

Roche (ROG: SIX) today revealed that the global Phase III randomized, double-blind, multicenter REMDACTA study of Actemra/RoActemra (tocilizumab) plus Veklury (remdesivir), versus placebo plus Veklury, did not meet its primary endpoint.

This was measured by improved time to hospital discharge up to day 28 in patients with severe COVID-19 pneumonia receiving standard of care. No new safety signals were identified for Actemra/RoActemra in the REMDACTA trial, the Swiss pharma giant said.

The study was conducted in collaboration with Gilead Sciences (Nasdaq: GILD), which markets Veklury, anti-viral agent that generated $1.9 billion sales in the fourth quarter of 2020. Veklury in October last year became the first drug to gain full US Food and Drug Administration approval for COVID-19. It was previously cleared under the emergency use system.