Ronapreve, a Roche and Regeneron-developed drug cocktail of casirivimab and imdevimab, gained marketing authorization from the European Commission last week for treatment of COVID-19 cases before hospitalization among adults and adolescents at least 12 years old.
Ronapreve can now be used in Europe to prevent cases of COVID-19. More specifically, to be used, patients must not require supplemental oxygen and must be at increased risk of progressing to severe COVID-19. Authorization followed a single day after positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), based on positive data from two studies: a treatment of non-hospitalized patients and a prophylaxis study of those exposed to the SARS-CoV-2 virus.
“We welcome this quick approval from the European Commission, which adds to the growing number of health authorities that recognize Ronapreve as an important therapy for the treatment and prevention of COVID-19,” Dr. Levi Garraway, Roche’s Chief Medical Officer and head of Global Product Development, said. “Although vaccinations are increasing globally, Europe is entering a fourth wave of rising cases, and treatment options for the full range of disease severity and variants of concern are still needed. We look forward to working with additional global regulatory bodies as we continue to tackle COVID-19 together.”
In the studies reviewed by CHMP, Ronapreve reduced hospitalized or death from COVID-19 by 70 percent and reduced symptom duration by four days. It also cut the risk of symptomatic infections by 81 percent in those uninfected before joining the trial.
Authorization of the drug in the EU followed similar approvals from Japan, the U.K., and Australia. It has also been authorized for emergency or temporary pandemic use in the United States, India, and Canada.
Roche intends to focus its efforts in the EU on extending the marketing authorization of Ronapreve to treat hospitalized patients with COVID-19 as well.