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Covid-19: FDA authorises neutralising antibody bamlanivimab for non-admitted patients

BMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m4362 (Published 11 November 2020) Cite this as: BMJ 2020;371:m4362

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  1. Elisabeth Mahase
  1. The BMJ

The monoclonal antibody treatment bamlanivimab has been given emergency use authorisation by the US Food and Drug Administration for treating mild to moderate covid-19 in adults and children not admitted to hospital.1

The FDA says that bamlanivimab has been shown to reduce covid-19 related hospital admission or emergency room visits in patients at high risk for disease progression in the 28 days after treatment when compared with placebo. Bamlanivimab acts against the SARS-CoV-2 spike protein to stop the virus attaching to and entering human cells.

The authorisation comes after Lilly, the company that makes bamlanivimab, announced last month that it would no longer test the drug on patients admitted to hospital with covid-19, as it was unlikely to help them. A week earlier a trial testing the drug on 326 inpatients with mild to moderate covid-19 (the Activ-3 trial) had been put on hold owing to safety concerns.2

However, other trials of the drug in non-admitted patients have continued. Results from Blaze-1, a phase II trial of bamlanivimab monotherapy and in combination with etesevimab—another neutralising antibody from Lilly—carried out in 465 non-admitted adults with mild to moderate covid-19 symptoms, have been submitted to the FDA for emergency authorisation.

The FDA announcement said that 101 participants in the trial received a 700 mg dose of bamlanivimab, 107 received 2800 mg, 101 received 7000 mg, and 156 received a placebo within three days of a first positive SARS-CoV-2 viral test.

“For patients at high risk for disease progression, hospitalisations and emergency room visits occurred in 3% of bamlanivimab treated patients on average compared to 10% in placebo treated patients,” said the agency, and similar effects were seen with all three doses of bamlanivimab.

Oxygen requirements

The FDA has approved bamlanivimab for patients with positive results of direct SARS-CoV-2 viral testing who are age 12 and older, weigh at least 40 kg, and are at high risk for progressing to severe covid-19 or hospital admission. This includes patients who are over 65 or have certain chronic medical conditions.

However, it emphasised that bamlanivimab should not be given to patients admitted with covid-19 or those requiring oxygen therapy, as such monoclonal antibodies may worsen outcomes in these patients.

Another potential antibody treatment for covid-19—REGN-COV2, a combination of two monoclonal antibodies (REGN10933 and REGN10987)—has also faced some issues among inpatients with high oxygen requirements. The manufacturer, Regeneron, has announced that the Independent Data Monitoring Committee for the company’s trials in covid-19 inpatients will be modified to stop any more patients who require high flow oxygen or mechanical ventilation from being recruited until further analysis has been carried out, because of a “potential safety signal and an unfavorable risk/benefit profile.”

Hospital inpatients requiring either no or low flow oxygen will continue to be enrolled, “as the risk/benefit remains acceptable in these cohorts,” the company’s statement said.

This information was shared with the Recovery trial’s committee, as REGN-COV2 is being tested as part of the study.3 After a review of the available safety and efficacy data for the 325 patients who were in the arm receiving either REGN-COV2 or control, the Independent Data Monitoring Committee found “no cogent reason to modify the protocol or intake to the study and recommended continuing recruitment of eligible patients to all study arms.”

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