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HomeCoronavirusFDA gives emergency use authorisation to bamlanivimab to treat COVID-19 patients

FDA gives emergency use authorisation to bamlanivimab to treat COVID-19 patients

Eli Lilly's bamlanivimab became the first monoclonal antibody drug to treat COVID-19 patients to receive emergency use authorisation (EUA) by the US Food & Drugs Administration.

MedPageToday reports Bamlanivimab was authorised to treat mild to moderate COVID-19 in both adult and paediatric patients who weigh at least 88 pounds and are at high risk of progressing to severe disease, the agency said on Monday. The therapy is to be administered intravenously as a single dose by healthcare providers.

However, the FDA emphasised that bamlanivimab was not for patients hospitalised with severe COVID-19 or who require oxygen therapy, and in fact noted that monoclonal antibodies may "be associated with worse clinical outcomes" in hospitalised patients "who require high-flow oxygen or mechanical ventilation." Lilly recently said it paused a clinical trial with the drug in this population.

Bamlanivimab is a recombinant monoclonal antibody targeting the SARS-CoV-2 spike protein. The U.S. government has contracted to buy 300,000 doses, to begin shipping immediately to distributor AmerisourceBergen, Lilly said in a statement. The Trump administration has committed to providing the drug without cost to patients, the company said.

"Weekly allocation decisions will be proportionally based on confirmed COVID-19 cases in each state and territory over the previous seven days, based on data from the U.S. Department of Health and Human Services' Protect data collection platform," Lilly said. "Each week, state and territorial health departments will select sites of care (that are accessible and can minimise infection transmission) to receive allocated doses and will provide AmerisourceBergen the list of sites. Sites of care will then confirm their need and AmerisourceBergen will distribute bamlanivimab overnight."

Lilly said it expects to produce "up to one million doses" by the end of 2020 with manufacturing capacity to "increase substantially" in 2021.

Authorisation was based on interim analysis of a phase II trial of 465 non-hospitalised adults with COVID-19 symptoms, in which patients were randomised to 700, 2,800 or 7,000 mg of bamlanivimab or placebo within 3 days of testing positive for SARS-CoV-2. Effects on viral load, hospital visits and safety were similar in all three drug doses of the therapy, the agency said.

The FDA said it was particularly impressed with bamlanivimab's effectiveness for the secondary endpoint of COVID-19 hospitalisations or emergency room visits within 28 days after treatment (3% in intervention vs 10% in placebo). The primary endpoint was change in viral load from baseline to day 11, with most patients, including those in the placebo group, clearing the virus within that timeframe.

Side effects of bamlanivimab include anaphylaxis and infusion-related reactions, nausea, diarrhoea, dizziness, headache, itching and vomiting.

 

[link url="https://www.medpagetoday.com/infectiousdisease/covid19/89581?xid=nl_covidupdate_2020-11-"]Full Reuters report[/link]

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