US revokes authorisation of one of Eli Lilly's COVID-19 monoclonal antibody treatments
Apr 17, 2021
Washington [US], April 17 : The US Food and Drug Administration (FDA) said on Friday that it has revoked it emergency authorisation of Eli Lilly's COVID-19 monoclonal antibody treatment bamlanivimab when used on its own.
According to CNN, the treatments use lab-made antibodies created specifically to target an infection. The FDA authorised the use of bamlanivimab to treat patients who had mild-to-moderate forms of COVID-19. An ongoing analysis of the treatment, found that on its own, it does not work well against some of the variants.
Bamlanivimab may still be used in combination with Lilly's other monoclonal antibody etesevimab. The Regeneron antibody treatment is also still authorised to be used in US by the FDA. The dual antibody treatments are still effective against the circulating variants, as reported by CNN.
The US regulatory body is still urging people to get these treatments if they have a mild-to-moderate form of COVID-19 and meet the criteria of the authorisation.
"While the risk-benefit assessment for using bamlanivimab alone is no longer favorable due to the increased frequency of resistant variants, other monoclonal antibody therapies authorised for emergency use remain appropriate treatment choices when used in accordance with the authorized labeling and can help keep high risk patients with COVID-19 out of the hospital," Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, said in a statement.
Cavazzoni added: "We urge the American public to seek out these therapies when needed while we continue to use the best data available to provide patients with safe and effective treatments during this pandemic."
The US body in February granted an emergency use authorisation to a monoclonal antibody cocktail made by pharmaceutical company Eli Lilly for treating coronavirus patients at high risk of developing severe COVID-19.
CNN reported that the new treatment adds etesevimab or LY-CoV016 to the already authorised bamlanivimab or LY-CoV555 to make a double-antibody version -- one that might be more protective, the company said. Rival Regeneron has a dual antibody - cocktail on the market already.
The FDA in November granted an emergency use authorisation (EUA) for Eli Lilly's investigational coronavirus antibody treatment called bamlanivimab.
