Widening the arsenal of drugs to combat COVID-19, a Switzerland-based drug maker, Roche has received approval from India's Central Drugs Standards Control Organisation (CDSCO) for use in emergency situations for treatment of COVID-19. The said experimental antibody cocktail was consumed by former US President Donald Trump when he contracted COVID-19 infection last year during his tenure at the White House.
Roche India and Cipla on Monday announced the launch of their Antibody Cocktail -- 'Casirivimab and Imdevimab' for the treatment of mild to moderate COVID-19 in patients in India. The first batch of the Antibody Cocktail has been made available in India and has been priced at Rs 59,750 per dose. Another batch is excited to be available in India by June.
The antibody cocktail is to be administered for the treatment of mild to moderate coronavirus disease 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 is a cocktail of two antibodies, casirivimab and imdevimab, and is used for the treatment of mild-to-moderate COVID-19 in high-risk patients. Casirivimab and imdevimab are monoclonal antibodies — or laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses. Casirivimab and imdevimab are specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’s attachment and entry into human cells. “Due to the specific engineering of two neutralising antibodies, which bind to different parts of the virus spike, the cocktail remains efficacious against widest spread variants and reduces the risk of losing its neutralisation potency against new emerging variants,” Roche said in a statement.
The cocktail is to be administered for the treatment of mild to moderate COVID-19 in adults and paediatric patients (12 or older) who are at high risk of developing severe disease. It 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. High-risk includes patients over 60 and/or those who have various comorbidities, such as cardiovascular disease, chronic lung or kidney disease, diabetes etc.
Roche announced that a large phase 3 global trial in 4,567 high-risk non-hospitalised COVID-19 patients met its primary endpoint, showing that the cocktail significantly reduced the risk of hospitalisation or death by 70% compared to placebo. Casirivimab and imdevimab also significantly shortened the duration of symptoms by four days, it said.
“We are focused on working towards access and timely delivery of supplies,” V Simpson Emmanuel, Managing Director, Roche Pharma India said by email. The company will import product batches to India and will market and distributed these through a strategic partnership with Cipla Limited. “It is too early to provide information on the specific amount of product that will be shipped to India and it’s pricing. We are in discussion with our marketing partner Cipla to support access to casirivimab and imdevimab for eligible patients in India. All details are being worked out and Cipla will be able to share the launch plan shortly,” Emmanuel said. At a global level, Roche and its partner Regeneron are collaborating to jointly address increasing demand, he said.
The drug currently has received Emergency Use Authorisation (EUA) in the US, where Trump had taken the drug when he contracted the disease, and the European Union. Roche said the approval granted in India was based on the data that have been filed for the EUA in the US, and the scientific opinion of the Committee for Medicinal Products for Human Use (CHMP) in the European Union.
Trump had touted antibody cocktail as a cure and key to his recovery. Albeit promising early results, the drug at the large clinical trials to test its safety and efficacy haven’t finished yet.