India approves Roche/Regeneron antibody cocktail to treat COVID-19
FILE PHOTO: A logo of Swiss pharmaceutical company Roche in Rotkreuz, Switzerland, April 12, 2012.
Indiahas given emergency use authorization for aCOVID-19antibody-drugcocktaildeveloped byRocheandRegeneron, expanding its arsenal of drugs to battle a massive second wave of infections.
The decision was taken based on data filed with the USregulators and the scientific opinion of a European regulatory panel, Roche's India distribution partner for the drug, Cipla, said on Wednesday.
The therapy is acocktailof two antibodies Casirivimab and Imdevimab, which are synthetically manufactured copies of antibodies that the body produces after an infection.
It has been shown to reduce hospitalizations inCOVID-19patients who are at a high risk of developing severe illness.
The drug already has similar authorization in the United States and is used in Europe non-hospitalised patients. Former USPresident Donald Trump had taken the drug when he contracted the disease.
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Cipla said the drug is meant for people with mild-to-moderate infection who are at high risk of developing severe disease. The company did not provide a price or a launch date.
In the last 10 days, more than 33,000Indians have died ofCOVID-19, with the country facing a severe shortage ofCOVID-19medicine including Gilead's remdesivir andRoche's tocilizumab.
Both government and local manufacturers have said they are working to ramp up production. SmallerIndian drugmaker Natco Pharma said on Monday it received emergency use authorization for baricitinib, originally developed by Eli Lilly, to be used with remdesivir totreatCOVID-19.
India's official tally of coronavirus infections has crossed 20 million and is second only to the United States. Deaths have reached 226,188, but experts say the real tally could be several times higher.