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

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.

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.