Chugai files for additional indications for Ronapreve in Japan

Japanese drugmaker Chugai Pharmaceutical (TYO: 4519), which is majority-owned by Roche (ROG: SIX), has filed an application with the Ministry of Health, Labor and Welfare (MHLW) for approval of additional indications for the anti-SARS-CoV-2 monoclonal antibody cocktail Ronapreve (casirivimab/imdevimab) for the prophylaxis of COVID-19 and treatment of asymptomatic COVID-19 infected patients.

This application also contains subcutaneous administration in addition to the drug’s current intravenous administration and seeks the Special Approval for Emergency.

“Since the Special Approval in July, Ronapreve has been used to prevent the progression of the disease in patients with mild to moderate COVID-19, supported by relevant stakeholders, including national, local governments and medical professionals. With this application, we aim to further contribute to the control of this infectious disease as a drug that can reduce the risk of developing COVID-19 in non-infected people who are in close contact with infected individuals and asymptomatic COVID-19 patients. We also aim to add subcutaneous administration for Ronapreve to provide flexibility in dosing that may better suit the condition of each patient and the healthcare provision system,” said Chugai’s president and chief executive, Dr Osamu Okuda.