“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 said.
Roche India on Wednesday announced that the Central Drugs Standards Control Organisation (CDSCO) has provided Emergency Use Authorisation (EUA) for Roche’s antibody cocktail in India for treatment of the coronavirus disease (Covid-19).
The product will be used to treat mild to moderate Covid-19 in adults and paediatric patients (12 years of age or older, weighing at least 40 kg) who are confirmed to be infected with SARS-COV2 and are at high risk.
“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,” V Simpson Emmanuel, managing director of Roche Pharma India, was quoted as saying. The drug will be available through leading hospitals and Covid-19 treatment centres in India.
In March, Roche said a large phase III global trial in high-risk non-hospitalised Covid-19 patients met its primary endpoint, which showed casirivimab and imdevimab significantly reduced risk of hospitalisation or death by 70% compared to placebo. The antibody cocktail also significantly shortened the duration of symptoms by four days, Cipla said.
Commenting on the partnership, 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. This partnership with Roche is a significant step in enabling access to promising treatments”
Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses. Casirivimab and imdevimab are monoclonal antibodies that are specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells.
Casirivimab and Imdevimab are approved at a combined dose of 1200 mg (600 mg of each drug) administered by intravenous infusion or subcutaneous route. It has to be stored at 2 °C to 8 °C.