Roche gets DCGI nod for its investigational antibody cocktail in India

Mumbai: Roche India has received an Emergency Use Authorisation (EUA) for its antibody cocktail (Casirivimab and Imdevimab) in India. This approval from the Central Drugs Standards Control Organisation (CDSCO) was based on the data that have 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.

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. The production process for this biologic medicine is very complex and Roche as one of the largest biologics manufacturers in the world was selected by its partner Regeneron to expand worldwide production capacity. Roche will do everything to ensure equitable distribution across the globe, however initial local demand may far exceed the supplies the company will be able to provide.

The antibody cocktail (Casirivimab and Imdevimab) is to be administered for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) 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-hospitalized COVID-19 patients (“outpatients”) met its primary endpoint, showing that Casirivimab and imdevimab significantly reduced the risk of hospitalization or death by 70% compared to placebo. Casirivimab and imdevimab also significantly shortened the duration of symptoms by four days.

‘With the increasing number of Covid-19 infections in India, Roche is committed to doing everything we can to minimize hospitalizations and ease pressure on healthcare systems. This is where neutralizing antibody cocktails like casirivimab and imdevimab can play a role in the fight against COVID-19 and in treatment of high risk patients before their condition worsens. We are thankful to the CDSCO for granting an EUA for casirivimab and imdevimab. 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.

Commenting on the partnership, Umang Vohra, MD and Global CEO Cipla said, “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’.

Cipla will market and distribute the product in India by leveraging its solid distribution strengths across the country. The drug will be available through leading hospitals and Covid treatment centers.