Pharma giant Roche India on Wednesday announced that the Central Drugs Standards Control Organisation (CDSCO) has provided Emergency Use Authorisation (EUA) for Roche’s antibody cocktail in India for treatment of the coronavirus disease (Covid-19).
“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.
The approval for the antibody cocktail— Casirivimab and Imdevimab— was based on the 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.
Both Casirivimab and Imdevimab are human immunoglobulin G-1 (IgG1) monoclonal antibodies produced by recombinant DNA technology.
{{/usCountry}}Both Casirivimab and Imdevimab are human immunoglobulin G-1 (IgG1) monoclonal antibodies produced by recombinant DNA technology.
{{/usCountry}}Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses. Casirivimab and imdevimab are monoclonal antibodies that are specifically directed against the spike protein of SARS-CoV-2, the virus that causes Covid-19, and designed to block 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 is to be administered for the treatment of mild to moderate Covid-19 cases in adults and pediatric patients (12 years of age or older, weighing at least 40 kg) who are confirmed to be infected with SARS-COV2, and who are at high risk of developing severe Covid-19 disease.
It could significantly help these high-risk patients before their condition worsens. On March 23 2021, Roche announced that a large phase III global trial (n=4,567) in high-risk non-hospitalised Covid-19 patients (”outpatients”) met its primary endpoint, showing that Casirivimab and imdevimab significantly reduced the risk of hospitalisation or death by 70% compared to placebo. Casirivimab and imdevimab also significantly shortened the duration of symptoms by four days.
Casirivimab and Imdevimab is approved at a combined dose 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.
This Emergency Use Authorisation will now enable Roche to import the globally manufactured product batches to India and will be marketed as well as distributed in India through a strategic partnership with Cipla Limited.
“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.