India okays  Roche’s antibody cocktail

CDSCO’s authorisation was based on the EUA in the US as well as the scientific opinion of the Committee for Medicinal Products for Human Use (CHMP) in the European Union.Premium
CDSCO’s authorisation was based on the EUA in the US as well as the scientific opinion of the Committee for Medicinal Products for Human Use (CHMP) in the European Union.
 1 min read . Updated: 06 May 2021, 12:22 AM IST Leroy Leo

NEW DLEHI : Roche India on Wednesday said the Central Drugs Standards Control Organisation has given it emergency use authorization for the antibody treatment that was given to former US President Donald Trump after he was diagnosed with covid-19, offering doctors in India another option to treat those infected by the coronavirus.

Roche will import the antibody cocktail of casirivimab and imdevimab, which will be marketed and distributed in India through a strategic partnership with Cipla Ltd, which is also the exclusive importer and distributor of tocilizumab, patented by Roche India.

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An antibody cocktail is a mixture of two or more unique biological drugs that act like human antibodies in the immune system and help fight off infection.

The company said it will do everything to ensure equitable distribution across the globe, but initial demand in India may far exceed supplies. “With the increasing number of covid infections in India, Roche is committed to doing everything we can to minimize hospitalizations and ease pressure on the healthcare system. This is where neutralizing antibody cocktails, such as casirivimab and imdevimab, can play a role in the fight against covid and in treating high-risk patients before their condition worsens," V. Simpson Emmanuel, managing director, Roche Pharma India, said in a statement. In November, the drug got an emergency use authorization from the US Food and Drug Administration for treating covid, after clinical trials showed there was a reduction in covid-related hospitalization for patients with a high risk of disease progression within 28 days after treatment compared to a placebo.

Roche is manufacturing and distributing the drug developed by Regeneron Pharmaceuticals Inc. Last month, Roche announced results from its phase 3 global trial of 4,567 high-risk non-hospitalized covid patients, which showed the antibody cocktail reduced the risk of hospitalization or death by 70% compared to a placebo and also shortened the duration of symptoms by four days.

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