Roche India on May 5 said it received Emergency Use Authorisation (EUA) from the Central Drugs Standards Control Organisation (CDSCO) for the antibody cocktail Casirivimab and Imdevimab in India.
Cipla will market and distribute the product in India. The drug will be available through leading hospitals and COVID treatment centres.
This approval was based on the data that have 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.
"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 will do everything to ensure an equitable distribution across the globe, however initial local demand may far exceed the supplies the company will be able to provide," the company said.
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 have tested positive and are at high risk of developing severe COVID-19 disease.
It could significantly help these high-risk patients before their condition worsens.
On March 23 2021, Roche announced that a large phase III global trial (n=4,567) in high-risk non-hospitalised COVID-19 patients (outpatients) met its primary endpoint, showing that Casirivimab and imdevimab significantly reduced the risk of hospitalisation or death by 70 percent compared to placebo.
Casirivimab and imdevimab also significantly shortened the duration of symptoms by four days.
‘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," Roche said.
"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. This outpatient treatment for COVID-19 will be complementary to the ongoing vaccination drive and support our fight against the pandemic in India’, said Mr V Simpson Emmanuel, Managing Director, Roche Pharma India.
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 is 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.