Following the news that Roche has received emergency use authorization (EUA) for a COVID-19 antibody cocktail casirivimab and imdevimab; Prashant Khadayate, Pharma Analyst at GlobalData offers his view:

“Roche’s antibody cocktail casirivimab and imdevimab are among the only two drugs to be exclusively developed and approved for COVID-19 treatment. Bamlanivimab and etesevimab being the other antibody cocktail from Eli Lilly. Most of the approved therapies for COVID-19 are repurposed, where they showed benefits in COVID-19 patients, but the original drug was in development or approved for other indications.

According to GlobalData’s Pharma Intelligence Center, India is the second country to approve Roche’s COVID-19 antibody-drug cocktail casirivimab and imdevimab. In November 2020, the US was the first country to approve it. Moreover, Roche’s partner Regeneron has applied for US approval as a preventative treatment.

The Central Drugs Standards Control Organisation (CDSCO) of India has fast-tracked Roche’s antibody-drug cocktail approval based on the data with the US FDA and the scientific opinion of a European regulatory panel. The drug has shown to reduce hospitalizations in COVID-19 patients at a high risk of developing severe COVID-19.

India is currently struggling with the severe second wave of COVID-19 with more than 350,000 cases daily and with drug shortages as well. To improve the overall situation concerning a lack of available treatments, the CDSCO has recently approved Natco’s baricitinib to be used with remdesivir, Zydus Cadila’s Virafin (pegylated interferon alpha-2b) whereas Merck’s partner Natco has applied for emergency approval for molnupiravir in India.

Roche’s antibody cocktail will be distributed by its partner Cipla in India. Considering that it is a combination of two recombinant human immunoglobulin G-1 (IgG1) monoclonal antibodies, it is expected to be highly expensive compared to other treatment options available for mild to moderate patients and will not be an affordable treatment for many patients. Therefore, the drug will be primarily available for patients in metro and top-tier cities in India, where the number of patients who can afford this drug are high. Moreover, it needs to be seen how the cocktail antibody works against the new variants in India like the ‘double mutant’ variant and other variants being reported in India.”