Roche, Cipla to bring Casirivimab/Imdevimab Covid-19 drug to India
Roche India said that India’s Central Drugs Standards Control Organisation (CDSCO) has granted an emergency use authorisation (EUA) for the Casirivimab, Imdevimab antibody cocktail for the treatment of Covid-19.
The EUA will now allow Roche to import the globally manufactured product batches of Casirivimab/Imdevimab to India, which will be marketed and distributed in the country through a partnership with Cipla Limited.
Umang Vohra – MD and Global CEO of 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’.”
The Casirivimab and Imdevimab drug regimen is intended to be used for the treatment of mild to moderate Covid-19 in both adults and pediatric patients, aged 12 years or older and weighing at least 40kg.
V. Simpson Emmanuel – Managing Director of Roche Pharma India said: “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.
“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.”
The emergency approval for the Covid-19 drug candidate was given by the CDSCO on the basis of the data filed by the company’s parent – Roche for the EUA in the US, and also the scientific opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) in the European Union.
According to Roche, the production process for the Covid-19 antibody cocktail is highly complex and it has been selected by its partner Regeneron Pharmaceuticals for expanding its production capacity globally.
Last month, Cipla forged a non-exclusive licensing agreement with MSD (called Merck in the US and Canada) for the manufacturing and distribution of Molnupiravir ((EIDD-2801/MK-4482), an investigational oral antiviral drug for Covid-19 treatment in patients who are not hospitalized.