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Roche's COVID-19 antibody cocktail receives Emergency Use Authorisation, Cipla to distribute the drug

"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.

May 06, 2021 / 07:44 AM IST
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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.


COVID-19 Vaccine

Frequently Asked Questions

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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"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.
Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
first published: May 5, 2021 06:01 pm

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