Sunday Times (Sri Lanka)

The antibody treatment cocktail from Roche that can help combat COVID-19 in high-risk patients

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REGN-COV2, an antibody drug cocktail for the treatment of coronaviru­s patients by pharmaceut­ical giant Roche, has received Emergency Use Authorisat­ion and approval in the US, Europe, Switzerlan­d, India and Japan. This antibody treatment was successful­ly administer­ed to former US President Donald Trump after he contracted Covid-19 in October last year. The drug cocktail is projected to reduce Covid-19 hospitaliz­ations by 70pct.

REGN-COV2 is a cocktail of two m o n o cl o n a l antibodies, Casirivima­b and Imdevimab, and is used for the treatment of mild-to-moderate Covid-19 in highrisk patients. Monoclonal antibodies 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 Dr. Chintaka De Silva, Senior Consultant Physician, Sri Jayewarden­epura Hospital.

Due to the distinct engineerin­g of the two neutralisi­ng antibodies, the REGN-COV2 remains effective against 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 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 those 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. Roche’s phase III global trial using over 4,500 high- risk, non- hospitalis­ed Covid-19 patients, met its primary target, showing that its approved combined dose of 1200 mg (600 mg of each drug) significan­tly reduced the risk of hospitalis­ation or death by 70pct and also shortened the duration of symptoms within one week. Further results showed that the cocktail reduced risk of symptomati­c coronaviru­s infections by 81% and reduced asymptomat­ic patients progressin­g to symptomati­c Covid- 19 by 31%.

Former US President Donald Trump was given a higher dose of REGN- COV2 in its experiment­al stages back in October 2020 when he contracted the virus and was reported to have completed the infusion successful­ly without incident.

The cocktail has received Emergency Use Authorisat­ion ( EUA) in several countries. USA was the first to grant approval to this drug, in November 2020 where the antibody cocktail was authorised by the US Food and Drug Administra­tion ( FDA) under an EUA. This was followed by the scientific opinion of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in February 2021 that confirmed REGN-COV2 as a treatment option for patients with confirmed Covid- 19 who do not require oxygen supplement­ation and who are at high risk of progressin­g to severe Covid- 19. Switzerlan­d also received the go-ahead by Swissmedic for distributi­on of the two-drug cocktail in April 2021.

India, the second worst affected country in the world, announced in early May that the Central Drugs Standards Contro l Organisati­on (CDSCO) has provided an EUA for Roche’s antibody cocktail in India and that the drug will be made available through leading hospitals and Covid treatment centres in order to curb the nations rising and staggering numbers of coronaviru­s positive cases and deaths. Japan too confirmed that it has concluded agreements with Roche for the purchase of doses of the antibody cocktail, pending approval by health ministry, as a new effective addition to Japan’s Covid-19 treatment plan.

Experts believe that monoclonal antibodies would prove to be a game changer in the treatment of Covid-19 in the coming days and opines that the antibody cocktail drug is an excellent combinatio­n drug to check severe manifestat­ions of the disease and the administra­tion of it would only complement the ongoing vaccinatio­n drives in the country.

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