FDAnews
www.fdanews.com/articles/197347-roche-to-test-actemra-with-remdesivir-for-covid-19

Roche to Test Actemra With Remdesivir for COVID-19

May 29, 2020

Roche has begun a phase 3 trial of its rheumatoid arthritis treatment Actemra (tocilizumab) with Gilead Sciences’ remdesivir for treatment of patients with severe COVID-19 pneumonia.

The REMDACTA trial will evaluate the safety and efficacy of Actemra plus remdesivir on top of standard of care in hospitalized patients receiving standard of care.

Patients will be randomized to receive Actemra with remdesivir and standard of care, or a placebo and remdesivir with standard of care.

The trial is expected to begin enrolling in June with a target of enrolling 450 patients globally. It is being conducted in collaboration with Gilead.

In addition, Roche is completing enrollment for a separate phase 3 trial of intravenous Actemra with standard of care in adults hospitalized with severe COVID-19 pneumonia.

The company is collaborating with the FDA and HHS’ Biomedical Advanced Research and Development Authority (BARDA) for the trial and expects to release trial data this summer. — Jordan Williams