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* Sri Lanka’s NMRA grants Emergency Use Approval of REGN-COV2 for COVID-19 treatment
Sat, Jun 26, 2021, 10:00 pm SL Time, ColomboPage News Desk, Sri Lanka.

June 26, Colombo: Sri Lanka’s National Medical Regulatory Authority (NMRA) has granted Emergency Use Authorization to antibody drug cocktail of casirivimab and imdevimab (REGN-COV2), produced by pharmaceutical giant Roche for the treatment of mild to moderate coronavirus disease 2019 (COVID-19).

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. 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 70 percent and fatality rate by 71 percent 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 81 percent and reduced asymptomatic patients progressing to symptomatic Covid-19 by 31 percent, while reducing the Oxygen dependency.

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.

Due to the distinct engineering of the two neutralizing antibodies, the REGN-COV2 remains effective against the widest spread variants and reduces the risk of losing its neutralizing 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 pediatric 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 centers. Earlier that month, India’s Central Drugs Standards Control Organization (CDSCO) approved the drug for Emergency Use Authorization in light of the country’s staggering death toll.

 

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