Roche antibody cocktail for post-exposure prophylaxis of Covid-19 for adults gets CDSCO panel okay
New Delhi: With the aim of reducing the spread of the Covid-19 epidemic, the Subject Expert Committee (SEC), functional under the Central Drug Standard Organization (CDSCO), has recently approved pharma major Roche Products (India) Pvt Ltd's investigational antibody cocktail casirivimab and imdevimab for use in post-exposure prophylaxis of COVID-19 for adults ≥ 18 years of age.
However, in the case of children, the Subject Expert Committee (SEC) has requested the drug firm to submit safety data from the Post Marketing Surveillance (PMS) study in India in children for the use of the drug cocktail casirivimab and imdevimab in COVID-19 post-exposure prophylaxis.
This recommendation came in response to the proposal presented by drug-maker Roche Products (India) Pvt Ltd for approval of an additional indication for use of the antibody cocktail (Casirivimab and Imdevimab) in post-exposure prophylaxis of COVID-19 based on clinical data generated overseas.
Casirivimab is a monoclonal antibody combined with Imdevimab in Regeneron's antibody cocktail known as REGN-COV2 for the treatment of COVID-19.This drug is a combination of antibodies derived from humanised VelocImmune mice in addition to blood samples from patients who have recovered from COVID-19. These antibodies have been formulated to bind to multiple locations on the SARS-COV-2 spike protein, preventing viral escape.
Casirivimab and Imdevimab are monoclonal antibodies that are specifically directed against the spike protein of SARS-CoV-2, designed to block the virus' attachment and entry into human cells.
Earlier, the Medical Dialogues Team had reported that drug firm Roche India had received Emergency Use Authorisation (EUA) from the Central Drugs Standards Control Organisation (CDSCO) for Roche's investigational antibody cocktail used in the treatment of COVID-19."
The approval of the antibody cocktail of Casirivimab and Imdevimab in India was based on the data filed with the EUA in the US, and the scientific opinion of the Committee for Medicinal Products for Human Use (CHMP) in the European Union.
It was also reported that the first batch of the Antibody Cocktail (Casirivimab and Imdevimab) was launched in the Indian market a few months ago, in a strategic partnership between Roche India and Cipla Limited. Further, it was said that Cipla will distribute the product across the country and the drug will be available through leading hospitals and COVID treatment centers.
Now in continuation, at a recent SEC committee meeting, the SEC committee thoroughly examined the proposal presented by Roche Products (India) Pvt Ltd for approval of an additional indication for use of the drug in post-exposure prophylaxis of COVID-19 based on clinical data generated overseas.
The committee noted that the additional indication is approved in the US, UK, and France.
After detailed deliberation, the committee concluded,
"The committee recommended grant of additional indication for post-exposure prophylaxis inline with US-FDA for adults ≥ 18 years of age. Further, the committee recommended that the firm should submit the safety data from the PMS study in India in children for consideration of the extension of indication to children."