NMRA grants Emergency Use Authorisation for COVID-19 antibody treatment cocktail

REGN-COV2, an antibody drug cocktail for the treatment of coronavirus patients by pharmaceutical giant Roche, has received Emergency Use Authorisation (EUA) by the National Medical Regulatory Authority (NMRA) of Sri Lanka. 

NMRA has approved the importation of REGN-COV2 antibody drug cocktail for the treatment of mild to moderate coronavirus patients in Sri Lanka who are at high risk, such as patients with cancer, immune suppression, kidney and bone marrow transplant, cardio diabetes, obese, and elderly patients of over age 60, including those who have chronic diseases, etc. 

The approval was granted by the NMRA following the granting of EUA of the drug in some countries, including the US (FDA), India, Switzerland, Japan, and several EU countries, such as Germany, France, Denmark, Netherlands, Italy, Sweden, Belgium, Estonia, Iceland, Czech Republic and also Israel and Serbia (non-Europe), in review and consideration of the medical data filed with the US regulators as well as the scientific opinion of a European regulatory panel. 

The drug cocktail is developed by pharmaceutical giants Roche and Regeneron and will be imported and distributed in Sri Lanka by SLIM Pharmaceuticals Ltd. This antibody treatment was successfully administered during the clinical stage to former US President Donald Trump when he contracted the virus in October last year and was reported to have completed the infusion successfully without incident. 

The Roche antibody drug cocktail is shown to reduce the risk of COVID-19 hospitalisations by 70% and fatality rate by 71% in high-risk patients and is proven to shorten the duration of symptoms within one week. Further results show that it also reduces the risk of symptomatic coronavirus infections by 81% and reduced asymptomatic patients progressing to symptomatic COVID-19 by 31%, while reducing oxygen dependency.

“The Roche Antibody Drug Cocktail is a game-changer in the treatment of COVID-19, and it is an excellent combination drug to check severe manifestations of the disease. The addition of this drug cocktail into our healthcare system would only complement the ongoing vaccination drives and strengthen our efforts in curbing the rising number of death reports in coronavirus patients in the country,” shared SLIM Pharmaceuticals Chairman Sumith Premaratne. 

REGN-COV2 is a cocktail of two monoclonal antibodies, casirivimab and imdevimab, which are two laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as a virus. Antibodies casirivimab and imdevimab were specifically designed against the spike protein of SARS-CoV-2, directed to block the virus’s attachment and entry into the human cells.

“Latest clinical trials results show the important medical benefit casirivimab and imdevimab (Roche antibody cocktail) may provide to people with COVID-19 by significantly reducing their risk of hospitalisation and death. This is very important for us to manage our patients as well,” said Sri Jayawardenapura Hospital Senior Consultant Physician Dr. Chintaka de Silva.

Due to the distinct engineering of the two neutralising antibodies, the REGN-COV2 remains effective against the widest spread variants and reduces the risk of losing its neutralising potency against any new emerging coronavirus variants. 

The two-drug cocktail is to be administered intravenously for the treatment of mild-to-moderate COVID-19 in adults and paediatric patients (12 or older) who are at high risk of developing severe disease. High-risk patients include anyone over 60 or those who are immunosuppressed, undergoing cancer treatment, bone marrow or organ transplant or having multiple illnesses such as cardiovascular disease, chronic lung or kidney disease, diabetes, etc. 

India, the second-worst affected country in the world, announced on 24 May that the Roche drug cocktail is now available for administration at leading hospitals and COVID treatment centres. Earlier that month, India’s Central Drugs Standards Control Organisation (CDSCO) approved the drug for EUA in light of the country’s staggering death toll.