India has approved Roche/Regeneron’s antibody cocktail for emergency use to treat Covid-19, as essential medical supplies run low in the country amid a devastating second wave of infections.
The country’s Central Drugs Standards Control Organisation (CDSCO) provided an Emergency Use Authorisation (EUA) for Roche’s antibody cocktail in India based on data that has been filed for the EUA in the United States and the scientific opinion of the Committee for Medicinal Products for Human Use (CHMP) in the European Union, Roche India said in a statement on Wednesday.
The drug is a combination of two monoclonal antibodies – casirivimab and imdevimab – that are produced in a laboratory. It is currently available in the United States to treat mild-to-moderate Covid-19 in people already infected with the coronavirus. Former US President Trump received the therapy when he was hospitalized for coronavirus.
“With the increasing number of Covid-19 infections in India, Roche is committed to doing everything we can to minimise hospitalisations and ease pressure on healthcare systems,” V. Simpson Emmanuel, the managing director of Roche Pharma India, said in a statement.
The EUA enables Roche to import the drug to India and it will be distributed through a partnership with Cipla Limited, the statement said.
“Roche will do everything to ensure an equitable distribution across the globe, however initial local demand may far exceed the supplies the company will be able to provide,” it added.
The latest numbers: The approval of Roche’s antibody cocktail for use in the country comes as the World Health Organization’s weekly Covid-19 report warned India accounts for 25% of the world’s Covid-19 deaths reported in the past week. On Wednesday, India recorded 382,315 new cases and a further 3,780 Covid-19 related deaths, according to health ministry figures.
Dozens of countries have pledged critical aid. Planeloads of ventilators, oxygen supplies and antiviral drugs began arriving last week but medical workers and local officials are still reporting the same devastating shortages that have strained the health care system for weeks now – raising questions, even among foreign donors, of where the aid is going.