Covid-19: Roche India gets emergency use approval for its antibody cocktail that prevents severe infection

The company is also seeking EUA for the antibody cocktail--Casirivimab and Imdevimab--in the United States and scientific opinion of the Committee for Medicinal Products for Human Use (CHMP) in the European Union.

“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. This is where neutralising antibody cocktails like casirivimab and imdevimab can play a role in the fight against Covid-19 and in the treatment of high risk patients before their condition worsens. This outpatient treatment for Covid-19 will be complementary to the ongoing vaccination drive and support our fight against the pandemic in India,” said V Simpson Emmanuel, managing director, Roche Pharma India.

Casirivimab and Imdevimab are human immunoglobulin G-1 (IgG1) monoclonal antibodies produced by recombinant DNA technology made in the laboratories. They target the spike protein of SARS-CoV-2 or the novel coronavirus, and are designed to stop the virus’ attachment and entry into human cells.

“Thanks to its specific engineering of two neutralising antibodies which bind to different parts of the virus spike, the Casirivimab and imdevimab cocktail remains efficacious against widest spread variants and reduces the risk of losing its neutralisation potency against new emerging variants,” the company said in a statement.

The antibody cocktail can be used to treat mild to moderate coronavirus infections in patients 12 years and above, weighing at least 40 kg and likely to develop severe Covid-19 disease. It can be used in high-risk patients before their condition worsens.

In March 23 2021, Roche said it has conducted large scale phase three global trials in high-risk non-hospitalised Covid-19 patients and the results revealed that "Casirivimab and Imdevimab significantly reduced the risk of hospitalisation or death by 70% compared to placebo"while also reducing the duration of symptoms by at least four days.

The medicine has been approved at a combined dose of Casirivimab and Imdevimab of 1200 mg (600 mg of each drug) administered by intravenous infusion or subcutaneous route. It has to be stored at 2 °C to 8 °C.

With the emergency use authorisation, Roche will now import the cocktail medicine to be marketed and distributed via a strategic partnership with Cipla Ltd.

“We are deeply committed to exploring all possible treatment options and being at the forefront in our fight against Covid-19. This partnership with Roche is a significant step in enabling access to promising treatments in furtherance to our purpose of ‘Caring for Life,” said Umang Vohra, MD and Global CEO Cipla.