Washington, Feb 13 (IANS) The US Food and Drug Administration (FDA) has issued an emergency use authorisation (EUA) to Eli Lilly’s bebtelovimab — an antibody that showed neutralisation against the Omicron variant, the company said.
Bebtelovimab is a neutralising IgG1 monoclonal antibody that binds to an epitope within the receptor binding domain of the spike protein of SARS-CoV-2.
The authorised dose of bebtelovimab is 175 mg given as an intravenous injection over at least 30 seconds.
The FDA has approved the use of bebtelovimab for the treatment of mild-to-moderate Covid-19 in adults and paediatric patients (12 years of age and older weighing at least 40 kg), and who are at high risk for progression to severe disease, including hospitalisation or death.
It can also be used for people on whom alternative Covid treatment options approved or authorised by FDA are not accessible or clinically appropriate.
The drug has also shown to neutralise the highly contagious and vaccine evading Omicron variant.
The FDA approval comes three weeks after Lilly’s antibody cocktail of bamlanivimab and etesevimab was banned by the regulator because it was shown to be ineffective against Omicron. Regeneron’s antibody, REGEN-COV, also was grounded that day for the same reason.
The EUA was granted based on analyses from the Phase 2, randomised, clinical trial evaluating treatment of non-hospitalised patients with mild-to-moderate Covid-19.
Pseudovirus and authentic virus testing demonstrated that bebtelovimab retains full neutralising activity against Omicron.
In addition, pseudovirus testing with bebtelovimab demonstrated that it retains neutralisation against all other known variants of interest and concern, including BA.2.
“With the emergence of variants such as Omicron, treatment options remain limited. Lilly is pleased to provide another treatment option to help address the ongoing needs of patients and health care providers who continue to battle this pandemic,” A said Daniel Skovronsky, Lilly’s chief scientific and medical officer, and president of Lilly Research Laboratories, in a statement.
Meanwhile, the US government has also signed an agreement with Lilly for 600,000 doses of the bebtelovimab drug for at least $720 million.
–IANS
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