Roche has announced that the US Food and Drug Administration (FDA) has formally approved its phase 3 trial of Actemra in severely ill COVID-19 patients, who have been hospitalised with pneumonia.
Actemra (tocilizumab) – an interleukin-6 inhibitor – has already been approved in China for the treatment of patients infected with the novel coronavirus disease, who have developed serious lung damage and also have elevated levels of IL-6 in the blood.
Previous research has suggested that elevated IL-6 – a biomarker for inflammation and a high-level immune response – is associated with a higher mortality in people with community-acquired pneumonia.
The investigation of Actemra’s use in COVID-19 is based on the hope that the drug could interrupt the process of ‘cytokine release syndrome’ (CRS), a form of serious inflammatory response that can occur as a complication of some infections.
It was first cleared by the FDA as a treatment for rheumatoid arthritis and has also subsequently been approved in juvenile idiopathic arthritis, giant cell arteritis and CRS associated with CAR-T cell therapies for cancer.
Roche had announced its intent to collaborate on a trial evaluating the drug in COVID-19 patients with the US Biomedical Advanced Research and Development Authority (BARDA) earlier this month.
The company has also committed to providing 10,000 vials of Actemra to the US Strategic National Stockpile for potential future use, and has also indicated that it has been working with distributors to manage product supply.
“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 enrol as quickly as possible,” said Alexander Hardy, chief executive officer of Roche’s Genentech unit.
The trial – named COVACTA – will recruit around 330 patients around the world, with an expected start date sometime in early April.
The primary and secondary endpoints will include assessing clinical status, mortality, mechanical ventilation and intensive care unit variables in the patient population.
Despite a number of clinical trials evaluating Actemra already ongoing across the world, =Genentech has maintained that the COVACTA study is pivotal because there are still no well-controlled studies and limited published evidence on the safety or efficacy of the drug in COVID-19.
Sanofi and Regeneron have also initiated a trial evaluating their own IL-6 inhibitor Kevzara (sarilumab) in the same indication – severely-ill COVID-19 patients who have been hospitalised.