Ronapreve – First Drug
F. Hoffmann-La Roche AG on July 2021, announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) approved ‘Ronapreve’ which is a combination of casirivimab and imdevimab – for the treatment with mild to moderate COVID-19 patients via intravenous route of drug administration. The antibody combination was granted a ‘Special Approval Pathway’ – under article 14-3 of the Pharmaceuticals and Medical Devices Act in Japan. The that Japan’s Ministry of Health, Labour and Welfare (MHLW) based the approval on results from the global phase III ‘REGN-COV 2067’ study in high-risk non-hospitalised COVID-19 patients. Outside Japan, the Ronapreve antibody combination drug has been authorised for emergency use in additional territories and regions, including in the United States, European Union, Switzerland, Canada, and India. It is also undergoing review by the European Medicines Agency and was granted a scientific opinion – under Article 5(3) of Regulation 726/2004, by the Committee for Medicinal Products for Human Use, that are supporting its use as a treatment option for patients with confirmed COVID-19.
The development and manufacturing of Ronapreve/ REGEN-COV have been funded with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), – part of the United State Department of Health & Human Services (HHS) Office of the ASPR (Assistant Secretary for Preparedness & Response), under OT number: HHSO100201700020
Japanese Special Approval for Emergency Use Drugs
Under article 14-3, Paragraph 1 – of the Japanese Act on Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices – the Minister of Health, Labour and Welfare (MHLW) approve a certain medical product that meets the following criteria with discussion with the Pharmaceutical Affairs and Food Sanitation Council of Japan:
- A pandemic condition requires an unapproved medical product including devices and drugs to be used to prevent damage to public health caused by the spread of diseases, and such emergency cannot be managed appropriately by any means other than the use of the unapproved product;
- Such product is legally available in a country with a regulatory system for medical products that is equivalent to Japan.
Ronapreve Combination of Casirivimab and Imdevimab
Ronapreve – combination of two monoclonal antibodies also known as REGN10933 and REGN10987, and was designed to block infectivity of ‘SARS-CoV- ‘–the virus that causes COVID-19. The 2 virus-neutralizing antibodies are believed to bind non-competitively to the critical receptor binding domain of the virus’s spike protein, which is hypothesized to reduce the ability of mutant viruses to escape treatment of COVID-19 and to protect against spike variants that may arise in the Japan population. In addition, a phase 3 trial for the prevention of COVID-19 in household contacts of infected individuals, showed subcutaneous administration of casirivimab and imdevimab reduced risk of symptomatic COVID-19 infections up to 81%.
F. Hoffmann-La Roche AG Retort to the COVID-19 Pandemic
F. Hoffmann-La Roche AG – leading healthcare company to support countries in their fight against COVID-19 and minimizing the COVID–19 Pandemic impact. Roche AG have developed a growing number of diagnostic solutions that help to detect as well as diagnose the infection, as well as providing digital support to healthcare systems in Japan and world. Roche AG continue to identify, develop and support potential therapies which can play a role in treating the disease. The impact of COVID-19 goes beyond those who contract it. The company are working with healthcare providers, laboratories, authorities and organizations to aid patients to continue receive the treatment and care they need during these challenging times in Japan. The company is focusing on building long term partnerships, and are working together with governments of Japan and others to make healthcare stronger and more sustainable in the future.
Limitations of Authorized Use
REGEN-COV (casirivimab and imdevimab) is not authorized for use in patients who are:
- hospitalized due to COVID-19, OR
- require oxygen therapy due to COVID-19, OR
- require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity
Benefit of treatment with REGEN-COV has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as REGEN-COV, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation