- Roche grant permission in India for mild and moderated covid-19 patients.
- It can reduce death by 70%.
- Cipla will be distributing it in India.
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.
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.
The prices for this drug are not yet revealed by the company.
“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’s 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.