Roche yesterday confirmed positive data from the phase II/III 2066 study, investigating Ronapreve (casirivimab and imdevimab) in patients hospitalised with COVID-19. The trial met its primary endpoint, showing that Ronapreve significantly reduced viral load within seven days of treatment in patients who had not mounted a natural antibody response of their own (seronegative) and who required low-flow or no supplemental oxygen (p=0.0172), a statement from the company notified.
“COVID-19 continues to devastate communities with over 4.7 million recorded deaths worldwide, the majority of which were in hospitalised patients. While vaccines are effective in preventing hospitalisations, a significant unmet need remains in many who still get infected, and whose disease requires hospital care,” said Levi Garraway, MD, PhD, Chief Medical Officer and Head, Global Product Development, Roche.
He further said, “These data add to previous findings that support the potential of Ronapreve in hospitalised patients, which may also help to ease pressure on healthcare systems.”
The study also reported clinical results supportive of the much larger UK Recovery trial in hospitalised patients showing that patients who received Ronapreve, (2,400 mg or 8,000 mg) in addition to the standard-of-care treatment, experienced numeric improvements across all clinical endpoints assessed, compared to the standard of care alone (placebo). Comparable clinical outcomes were recorded with both 2,400 mg and 8,000 mg doses. No new safety signals were identified, mentioned the statement.
The statement also said that the efficacy and safety of Ronapreve have been studied across multiple phase-III clinical trials in non-hospitalised and hospitalised COVID-19 patients, and in the preventive setting. Ronapreve is currently not authorised in patients who are hospitalised due to COVID-19 infection. Earlier this year, the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a scientific opinion supporting the use of Ronapreve as a treatment option for non-hospitalised patients with confirmed COVID-19.
Outside the European Union, Ronapreve has been approved for use in different patient populations in Japan and conditionally in the UK, and is authorised for emergency or temporary pandemic use in numerous territories including the United States, India and Canada. In addition, the World Health Organization (WHO) recently issued guidance regarding the use of Ronapreve for the treatment of certain patients with COVID-19. So far, it has been made available to patients in more than 40 countries via bilateral purchase agreements across many geographies and economies, including lower middle-income countries, it added.