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India approves Roche/Regeneron drug for Covid-19

It has been shown to reduce hospitalisations in Covid-19 patients who are at a high risk of developing severe illness
Last Updated 05 May 2021, 13:47 IST

Pharma major Roche and Regeneron on Wednesday received Emergency Use Authorisation (EUA) from the Central Drugs Standards Control Organisation (CDSCO) for its antibody cocktail Casirivimab and Imdevimab in India.

This approval 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.

This Emergency Use Authorisation will now enable Roche to import the globally manufactured product batches to India, and will be marketed and distributed in India through a strategic partnership with Cipla Limited, according to a press statement issued in Mumbai.

The antibody cocktail (Casirivimab and Imdevimab) is to be administered for the treatment of mild to moderate 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.

‘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 treatment of high risk patients before their condition worsens,” said V Simpson Emmanuel, Managing Director, Roche Pharma India.

Umang Vohra, MD & 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.”

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 centres.

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(Published 05 May 2021, 12:34 IST)

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