India grants Emergency Use Authorization to Roche’s Covid-19 Antibody Cocktail
The cocktail drug has been seen to reduce mortality risk in mild to moderate Covid-19 patients. It would be distributed in the country by Cipla.
India has granted Emergency Use Authorization to Roche and Regeneron’s COVID-19 antibody-drug cocktail, adding to its arsenal of drugs against Covid-19. The cocktail would be distributed and marketed by Roche’s India distribution partner Cipla in the country. The company has not provided a price or a launch date as of now.
Roche said the drug is meant for adults and pediatric (aged 12 or older) patients with mild-to-moderate infection who are at high risk of developing severe disease. It has reportedly been seen to help the patients before their condition worsens and reduce hospitalizations.
In the phase-3 trials of the drug carried out by the company, it was seen to reduce the risk of death by 70% and shortened the duration of symptoms by 4 days.
“This outpatient treatment for COVID-19 will be complementary to the ongoing vaccination drive and support our fight against the pandemic in India”, said Mr. V. Simpson Emmanuel, Managing Director, Roche Pharma India.
The therapy is a cocktail of two antibodies Casirivimab and Imdevimab, which are synthetically manufactured copies of antibodies that the body produces after being infected by the Coronavirus.
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. As per Roche, it shows efficacy against the widest spread variants. “It also reduces the risk of losing its neutralization potency against new emerging variants,” says the company.
The cocktail drug has already received authorization in the US and in Europe for non-hospitalized patients and was granted approval in India by the Central Drugs Standards Control Organization (CDSCO) on the basis of data filed with the US regulators as well as the scientific opinion of a European regulatory panel.
The antibody treatment was also administered to former US President Donald Trump under “compassionate grounds” after he was diagnosed with COVID-19.
The approval of this drug could significantly aid India in its efforts to curb Covid-19 as the country continues to witness record cases. Over 33,000 Indians have died of Covid-19 in the past 10 days. The country is facing a severe shortage of COVID-19 medicines, including Gilead’s Remdesivir and Roche’s Tocilizumab.
Earlier this week, on Monday, Indian drugmaker Natco Pharma had received Emergency Use Authorization for Baricitinib, originally developed by Eli Lilly, to be used with Remdesivir to treat COVID-19.
However, despite the numerous drugs being given authorization for use against Covid-19 in the country, lack of and non-adherance to prescription guidelines has led to a void that private practitioners are filling in themselves.
With no conclusive evidence of a medicine against Covid-19, doctors are prescribing dozens of drugs even for mild cases, and in many cases even ignoring prescription guidelines of the same. This is leading to a situation of chaos amongst patients and shortage of the drugs for severe cases who actually need them.
