Lilly India gets nod for restricted EU of monoclonal antibody drugs, bamlanivimab and etesevimab to treat COVID-19   

Eli Lilly and Company, India announced that it has received permission for restricted emergency use of its antibody drugs, bamlanivimab 700 mg and etesevimab 1400 mg, in India for the treatment of patients with mild to moderate coronavirus disease 2019 (COVID-19).  Bamlanivimab and etesevimab together are indicated for restricted use in emergency situation, IV route for the treatment of mild to moderate corona virus disease 2019 (COVID-19) for injection administration in hospital settings in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with RT-PCR positive results of direct SARS-COV2 viral testing and who are at high risk for progressing to severe COVID-19 and/or hospitalisation and do not require oxygen.  The company informed that it is engaging 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 Authorization in the US and select EU countries, for the treatment of mild to moderate COVID-19.

Luca Visini, MD, India Subcontinent, Lilly India, said, “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. 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.”

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 coronavirus disease 2019 (COVID-19 in hospitalized adults requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).