PandemicPreparedness

26 March: The U.S. Government has halted the distribution of Eli Lilly’s antibody LY-CoV555, also known as bamlanivimab, as monotherapy for COVID-19. This is due the increasing number of variants which are resistant to this monotherapy.

Combination treatment of bamlanivimab and etesevimab can continue.

9 February: The FDA has issued another emergency use authorization (EUA) to Eli Lilly for a combination of monoclonal antibody treatments; bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) together. The approved treatment can be given to adults and children over 12 years of age at risk for hospitalisation or severe COVID-19 disease. They are however not authorized for hospitalised patients who require oxygen therapy.

See news story on earlier study results and ongoing clinical trials of LY-CoV555.

9 November: The FDA has issued an emergency use authorization (EUA) for bamlanivimab, the monocolonal antibody (also known as LY-CoV555) developed by Eli Lilly. The treatment can now be given to mild-moderate COVID-19 patients aged 12 and over, and to those who are at risk of progressing to severe disease or hospitalisation. However it is not approved for people who are hospitalised or receiving oxygen.

9 October: Bloomberg reports that Eli Lilly has asked the US FDA for emergency use authorisation of its experimental COVID-19 single antibody therapy after data showed the treatment reduced hospitalizations. Authorisation would allow high-risk patients recently diagnosed with mild-to-moderate COVID-19 to receive the therapy.

Regeneron’s REGN-COV2 antibody therapy containing two antibodies, REGN10933 and REGN10987, is currently being studied in the Phase 3 Recovery trial of hospitalized COVID-19 patients in the UK, and a Phase 3 trial for the prevention of COVID-19 in uninfected people who are at high-risk of exposure to a COVID-19 patient, such as the patient’s housemate.

Eli Lilly is also studying a cocktail of two antibodies and expects to approach regulators for authorization in November and seek full approval in the second quarter of 2021.