Key statement on the emergency use authorisation and supply of the investigational antibody cocktail casirivimab and imdevimab in India.
On May 4, Roche India received an emergency use authorisation (EUA) for the investigational antibody cocktail casirivimab in India. This EUA was based on the data that have been filled for the EUA in the US and the CHMP scientific opinion in the European Union.
The EUA in India will enable the import of globally manufactured product batches to the country and support our fight against the pandemic in India. It will be marketed as well as distributed in India through a strategic partnership with Cipla Limited.
With the increasing number of infections in India, we must do everything we can to minimise hospitalisations and ease pressure on healthcare systems. This is where neutralising antibody cocktails may play a role in the fight against COVID-19, in treatment of high risk patients before their condition worsens.
Roche will do everything to ensure an equitable distribution of this product across the globe, however initial local demand may far exceed the supplies the company will be able to provide. We will continue to collaborate with our partners at the global level with authorities and distributors in India to help mitigate the health crisis in the country as much as we can.