Roche Cipla. Roche gets Emergency Use nod for Antibody Cocktail for mild-to-moderate Covid-19

Roche India on Wednesday received Emergency User Authorisation (EUA) from regulator - Central Drugs Standards Control Organisation (CDSCO) for antibody cocktail (Casirivimab and Imdevimab) to be used for treatment of mild to moderate Covid-19 in adults and kids aged 12 years or older in India.

The approval was based on the data 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.

The EUA will enable Roche to import the globally manufactured product batches to India. Company will market and distribute these products in India through its strategic partner Cipla Limited.

The antibody cocktail (Casirivimab and Imdevimab) is seen useful for high-risk patients before their condition worsens.

Phase 3 trial results

On March 23 2021, Roche announced that a large phase III global trial (with 4,567 participants) 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 per cent compared to placebo.

Casirivimab and imdevimab also significantly shortened the duration of symptoms by four days, the company informed in a statement issued on Wednesday. Casirivimab and Imdevimab are human immunoglobulin G-1 (IgG1) monoclonal antibodies produced by recombinant DNA technology.

“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,” said V Simpson Emmanuel, Managing Director, Roche Pharma India.

“This outpatient treatment for Covid-19 will be complementary to the ongoing vaccination drive and support our fight against the pandemic in India,” he added.

Commenting on the partnership, Umang Vohra, MD & 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.”

The drug will be available through leading hospitals and Covid treatment centres, it added. It has to be stored at 2 °C to 8 °C.

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 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 informed.

Mechanism of action

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.

Thanks to its specific engineering of two neutralising antibodies which bind to different parts of the virus spike, the Casirivimab and imdevimab cocktail remains efficacious against widest spread variants and reduces the risk of losing its neutralisation potency against new emerging variants.

The company has recommended doses for Casirivimab and Imdevimab. It is approved at a combined dose of 1200 mg (600 mg of each drug) administered by intravenous infusion or subcutaneous route.

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