Once Given To Trump, This Antibody Drug Cocktail Receives Emergency Approval To Treat Covid-19 In India

India’s Central Drugs Standards Control Organisation (CDSCO) has given emergency use approval to an investigational antibody cocktail for Covid-19 treatment.

It is a cocktail of casirivimab and imdevimab—developed by Switzerland based Roche and American biotechnology company Regeneron.

In October 2020, when former US President Donald Trump was admitted at the Walter Reed National Military Medical Center after testing positive for Covid-19, he received this antibody cocktail drug, also known as REGN-COV2.

The emergency approval was granted by the CDSCO based on data filed with the US regulators and scientific opinion from a European regulatory panel.

It is believed that this decision will further expand India’s arsenal of drugs to fight against the massive surge in Covid-19 cases during the second wave of the pandemic.

In a statement, the Indian company Cipla said that it will market and distribute the cocktail drug in the country by leveraging its solid distribution strengths across the nation.

“The drug will be available through leading hospitals and Covid treatment centres,” it added.

Details About This Antibody Drug Cocktail

It is a mixture of casirivimab and imdevimab that is used to treat those who are high-risk patients and diagnosed with mild-to-moderate Covid-19.

The European Medicine Agency (EMA) said in February this year that according to the completion of the review of the cocktail-drug “REGN-COV2 can be used for the treatment of confirmed Covid-19 in patients who do not require supplemental oxygen and who are at high risk of progressing to severe Covid-19”.

A study published in The New England Medical Journal of Medicine concluded that the "antibody cocktail reduced viral load, with a greater effect in patients whose immune response had not yet been initiated or who had a high viral load at baseline".

According to Roche, the phase III trial data showed that REGN-COV2 can reduce Covid-19 related hospitalisation and deaths by 70 per cent in non-hospitalized coronavirus patients.

It was also found that the antibody cocktail drug can significantly shorten the duration of Covid-19 symptoms by four days.

“The 2,400 mg and 1,200 mg doses tested in the phase III study had similar efficacy across all endpoints,” Roche said.

Both the drugs, casirivimab and imdevimab are monoclonal antibodies—laboratory-made protein—that are specifically directed against the spike protein of SARS-CoV-2.

These antibodies mimic the immune system’s ability to fight off harmful pathogens such as viruses.

These drugs are designed to block the virus’s attachment and invasion into the human cells.

“Thanks to its specific engineering of two neutralising antibodies which bind to different parts of the virus spike, the casirivimab and imdevimab cocktail remains efficacious against widest spread variants and reduces the risk of losing its neutralisation potency against new emerging variants,” wrote Cipla in its website.

REGN-COV2 is specifically for those who have mild to moderate coronavirus infection—specifically for adults and paediatric patients (12 or above)—and are at high risk of developing severe Covid-19.

“Casirivimab and Imdevimab are approved at a combined dose of 1200 mg (600 mg of each drug) administered by intravenous infusion or subcutaneous route. It has to be stored at 2 Degree Celsius to 8 Degree Celsius,” added the statement.

However, in terms of the availability of REGN-COV2 in India, Simpson Emmanuel, Managing Director, Roche Pharma India told The Indian Express: “We are focused on working towards access and timely delivery of supplies.”

Emmanuel also said that it would be too early to share information on the specific amount of product that will be shipped to India.

The company also has not disclosed any details about the price of REGN-COV2.

“We are in discussion with our marketing partner Cipla to support access to casirivimab and imdevimab for eligible patients in India. All details are being worked out and Cipla will be able to share the launch plan shortly,” Emmanuel added.