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Eli Lilly gets DCGI emergency use approval for COVID-19 antibody cocktail drug

Lilly said it is engaged in active dialogue with the Indian government and regulatory authorities to donate bamlanivimab and etesevimab in order to speed up access and provide treatment options for patients with COVID-19.

June 01, 2021 / 12:52 PM IST
Eli Lilly has partnered with Cipla, Lupin, Sun Pharma to manufacture and distribute Baricitinib in India

Eli Lilly has partnered with Cipla, Lupin, Sun Pharma to manufacture and distribute Baricitinib in India

US-drug maker Eli Lilly on June 1 said it had received approval for restricted emergency use of its antibody cocktail drugs, bamlanivimab 700mg and etesevimab 1400mg, in India for the treatment of patients with mild to moderate coronavirus disease (COVID-19).

Bamlanivimab and etesevimab are given together through injection in hospital settings in adults and pediatric COVID-19 positive patients (12 years of age and older weighing at least 40 kg) and who are at high risk for progressing to severe COVID-19 and hospitalisation and do not require oxygen.

Lilly said it is engaged in active dialogue with the Indian government and regulatory authorities to donate bamlanivimab and etesevimab in order to speed up access and provide treatment options for patients with COVID-19.

Bamlanivimab and etesevimab together have been authorised under Emergency Use Authorisation in the US and select EU countries, for the treatment of mild to moderate COVID-19.

Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses. Bamlanivimab and etesevimab 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. Bamlanivimab and etesevimab bind to different but overlapping sites on the spike protein of the virus.

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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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This will be the second cocktail drug approved by DCGI for emergency use. The drug regulator in May approved Roche's antibody cocktail Casirivimab and Imdevimab in India.

“We are pleased that we have another innovative treatment option to offer India’s healthcare providers who continue to be at the forefront of the battle against COVID-19," said Luca Visini, Managing Director, India Subcontinent, Lilly.

"Lilly is committed to contributing to the alleviation of the COVID-19 pandemic in India and around the world. We will continue to assess and evaluate how our existing portfolio and ongoing research can benefit patients with COVID-19,” Visini added.

Earlier in May, Lilly had also received permission for the emergency use of baricitinib in combination with remdesivir, for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalised adults requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Lilly said it has already made available a donation of more than 650,000 tablets of Baricitinib to the Indian government and issued eight voluntary licenses to Indian pharmaceutical manufacturers of generic medicines to accelerate and expand the availability of baricitinib to patients in India.
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: Jun 1, 2021 12:51 pm

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