The US Food and Drug Administration (FDA) has approved an emergency use authorisation (EUA) for American pharmaceutical company Eli Lilly’s experimental COVID-19 antibody treatment called ‘bamlanivimab’ for non-hospitalised patients with mild-to-moderate symptoms.
“The FDA’s emergency authorisation of bamlanivimab provides health care professionals on the frontline of this pandemic with another potential tool in treating COVID-19 patients,” said Patrizia Cavazzoni, M.D., acting director of the FDA’s Center for Drug Evaluation and Research in a press statement. While giving the EUA, the US administration specified that emergency use is different than FDA approval.
“In determining whether to issue a EUA, the FDA evaluates the available evidence and carefully balances any known or potential risks with any known or potential benefits of the product for use during an emergency,” the statement said.While the safety and effectiveness of this investigational therapy continue to be evaluated, bamlanivimab was shown in clinical trials to reduce COVID-19-related hospitalisation or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo, it added.
According to the FDA, the investigational drug could be effective for the treatment of mild to moderate COVID-19 cases in adults and children who are 12 years of age and older and who are at risk of needing hospitalisation. Eli Lilly and Company said that the FDA’s decision was a crucial development in the fight against the coronavirus.”Today’s emergency use authorisation for Lilly’s investigational #COVID19 antibody is a key moment in the fight against this disease. There’s more work to be done, but we’re proud of this contribution to the global effort to beat COVID-19,” the Eli Lilly and Company tweeted. FDA said the company will now pass bamlanivimab to authorised distributors who will then supply healthcare facilities with the new treatment, as directed by the US government and in collaboration with local authorities.