The FDA has approved a randomized, double-blind, placebo-controlled phase III study into the efficacy and safety of intravenous Actemra (tocilizumab) for treating COVID-19, the disease caused by the novel coronavirus SARS-CoV-2.
The study will be a co-venture between Roche and the Biomedical Advanced Research and Development Authority.
The study will investigate mortality, clinical status, intensive care unit and mechanical ventilation variables.
There are numerous independent clinical studies going on globally into the safety and efficacy of Actemra for COVID-19 treatment. There are no well-controlled studies into this, though, and the amount of data out there regarding the efficacy or safety of Actemra for COVID-19 treatment is limited. This means that this new FDA approval is absolutely vital.
There are currently no FDA-approved COVID-19 treatments.
The news comes as reports out of China say doctors in China saw a 95% success rate in treating severe COVID-19 symptoms with Actemra.
Doctors in China gave Actemra to 20 severely ill COVID-19 patients with an immune system overreaction and claim 19 of them left the hospital within two weeks. They said the other is recovering well.
Severe cytokine release syndrome (CRS), also known as a “cytokine storm,” is a symptom seen in some severe cases of COVID-19. CRS is a runaway inflammation response where the body’s immune system overreacts and does damage to the body. CRS can cause organ failure or death.
Actemra works against rheumatoid arthritis by inhibiting levels of the Interleukin 6 (IL-6) protein. This protein causes inflammation and Actemra reduces inflammation. China’s National Health Commission said that Actemra’s inflammation reducing properties mean it can treat the severe lung damage sometimes caused by COVID-19.
Genentech is providing 10,000 vials of Actemra to the U.S. Strategic National Stockpile. The drug will be reserved for future use at the U.S. Department of Health and Human Services’ direction.
Over 519,000 cases of COVID-19 have been reported in over 200 countries and territories. About 23,500 deaths have been reported from the disease. The United States has seen 79,313 cases of the disease, leading to 1,081 deaths. Many people with COVID-19 are asymptomatic or have mild symptoms like fever, fatigue, muscle pain, cough or shortness of breath. More severe cases can involve pneumonia, acute respiratory distress syndrome, sepsis, septic shock or death.
Actemra was in the news cycle in 2017. An investigation found that Actemra could be linked to an increased risk of pancreatitis, heart failure, interstitial lung disease and stroke.