Actemra coronavirus clinical trial : Genentech gets FDA nod for COVID-19 trial
Actemra coronavirus clinical trial : Genentech has been given approval by the US Food & Drug Administration (FDA) to undertake the phase 3 COVACTA trial to assess the safety and efficacy of intravenous Actemra (tocilizumab) along with standard of care in hospitalized adults having severe COVID-19 pneumonia.
The Roche subsidiary will carry out the randomized, double-blind, placebo-controlled COVID-19 clinical trial in collaboration with the Biomedical Advanced Research and Development Authority (BARDA).
Actemra is a humanized interleukin-6 (IL-6) receptor antagonist, which has FDA approval for the treatment of adults having moderately to severely active rheumatoid arthritis (RA) who have used at least one disease-modifying antirheumatic drug (DMARD), such as methotrexate (MTX), that did not give them enough relief.
The primary and secondary endpoints of the Actemra coronavirus clinical trial include clinical status, mortality, intensive care unit (ICU), and mechanical ventilation variables. Patients taking part in the COVID-19 clinical trial will be followed for 60 days post-randomization, and an interim analysis will be carried out to look for early evidence of efficacy, said Genentech.
Roche subsidiary Genentech gets FDA approval to begin Actemra coronavirus clinical trial. Photo courtesy of Gerd Altmann from Pixabay.
Genentech said that to further support the response of the US government against the coronavirus pandemic, it will supply 10,000 vials of Actemra to the US Strategic National Stockpile for potential use in the future at the direction of the US Department of Health and Human Services (HHS).
Commenting on the Actemra coronavirus clinical trial approval from the FDA, Alexander Hardy – CEO of Genentech, said: “We thank the FDA for rapidly expediting the approval of this clinical trial to evaluate Actemra in critically ill patients suffering from pneumonia following coronavirus infection and we’re moving forward to enroll as quickly as possible.
“Conducting this clinical trial in partnership with BARDA and providing Actemra to support the national stockpile, through the efforts of Secretary Azar and HHS, are important examples of how the U.S. government, the biotechnology industry and healthcare communities are working together in response to this public health crisis.”
According to Genentech, so far, various independent clinical trials have been launched across the world to explore the efficacy and safety of Actemra for the treatment of coronavirus pneumonia. However, the Roche subsidiary says that the new COVID-19 clinical trial in the US is crucial as there are no well-controlled studies and limited published evidence on the safety or efficacy of Actemra in the treatment of coronavirus.