Antibody cocktail receives EUA for COVID-19 treatment

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REGN-COV2, an antibody drug cocktail for the treatment of coronavirus patients by pharmaceutical giant Roche, has received Emergency Use Authorization (EUA) and approval in the US, Europe, Switzerland, India and Japan. The antibody treatment, which was successfully administered to former US President Donald Trump when he contracted COVIC-19 in October last year, is projected to reduce COVID- 19 hospitalizations by 70%.

A cocktail of two monoclonal antibodies, Casirivimab and Imdevimab, REGN-COV2 is used for the treatment of mild-to-moderate COVID-19 in high-risk patients. Monoclonal antibodies are two laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as a virus. Casirivimab and Imdevimab were specifically designed against the spike protein of SARS-CoV-2, directed to block the virus’ attachment and entry into the human cells. Due to the distinct engineering of the two neutralizing antibodies, REGN-COV2 remains effective against 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 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 immune-suppressed, 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-hospitalized 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 hospitalization or death by 70% 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 Authorization (EUA) in several countries. USA was the first to grant approval to the drug in November 2020 when the antibody cocktail was authorized 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 Control Organization (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.

Switzerland-based pharmaceutical company Roche is a global pioneer and is the world’s largest biotech company and is a world leader in diagnostics. In August 2020, Roche collaborated with US pharmaceutical company Regeneron to develop, manufacture and distribute the REGN-COV2 anti-viral, antibody cocktail to people globally.

Roche is committed to making REGN-COV2 available to COVID-19 patients around the world and has expressed its willingness to support access in low and lower-middle income countries through drug donations in partnership with public health organizations.

 

 

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