NMRA grants emergency use approval for COVID-19 antibody treatment cocktail

The National Medical Regulatory Authority (NMRA) of Sri Lanka has granted emergency use authorization for REGN-COV2, an antibody drug cocktail for the treatment of coronavirus patients by pharmaceutical giant Roche.

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 grant of Emergency Use Authorization (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 (Pvt) 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 hospitalizations by 70pct and fatality rate by 71pct in high-risk patients and is proven to shorten the duration of symptoms within one week. Further results show that it also reduces risk of symptomatic coronavirus infections by 81pct and reduced asymptomatic patients progressing to symptomatic Covid-19 by 31pct, while reducing the 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.” shares Sumith Premaratne, Chairman of SLIM Pharmaceuticals.

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 hospitalization and death. This is very important for us to manage our patients as well” said Dr. Chintaka De Silva, Senior Consultant Physician, Sri Jayawardenapura Hospital.

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 24th 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 Emergency Use Authorization in light of the country’s staggering death toll. (Colombo Gazette)


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