Roche’s casirivimab and imdevimab gets emergency use authorisation in indiaMay 6, 2021 0 By FM
According to Roche India, it has received ‘Emergency Use Authorization’ (EUA) for its investigational drug combination, Casirivimab and Imdevimab, for the treatment of CoViD-19 patients in India. The Central Drugs Standards Control Organization granted the approval considering the opinion of the Committee for Medicinal Products for Human Use (CHMP) in the European Union and EUA approval in US. The drug-combo could also shorten the duration of CoViD-19 symptoms to about 4 days. This can be helpful during the current CoViD-crisis in the country where hospitals are almost full.
The present authorization for ‘Emergency Use’ will now enable Roche to import its internationally manufactured product batches to India so that they can be marketed as well as distributed in India. The marketing within India will be made through a strategic partnership with the Indian pharmaceutical company, Cipla. As the production processes for Casirivimab and Imdevimab are very complex, the manufacturing effort will be shared by Regeneron, its partner to expand the worldwide production capacity.
The drug combination, Casirivimab and Imdevimab is intended to be used for the treatment of mild to moderate CoViD-19, in adults as well as children. In case of pediatric patients, they must be 12 years of age or older, weighing at least 40 kg. But before deciding to administer the drug-combo, it must be confirmed that the children are infected with SARS-CoV-2 and they are at a high risk of developing severe and life-threatening symptoms CoViD-19. disease. This cocktail of neutralizing antibodies cocktails can play a role in the fighting against CoViD-19 and in the treatment of patients with severe symptoms, before their condition worsens.
On 23 March 2021, Roche announced the results of a large phase III global trial. The peculiarity of this study group was that they were non-hospitalized patients who were tested positive to SARS-CoV-2 and remaining home. The results of the trial were so promising that Casirivimab and Imdevimab of progression of the disease and significantly reduced the risk of hospitalization and death by 70% compared to the placebo (control) group.
The recommended dosage is a combined dose of 1200 mg (600 mg of each drug) by intravenous infusion or subcutaneous injection. It has to be stored at 2 °C to 8 °C. According to the scientific part, Casirivimab and Imdevimab are human immunoglobulin G-1 (IgG1) monoclonal antibodies which are artificially created in the laboratories. They are specifically designed to act against the spike protein of SARS-CoV-2, which are the main protein-intermediates that are involved in blocking the attachment of the virus upon human cells and the subsequent entry into them.