Europe Begins Rolling-Review of COVID-19 Antibody Treatments

The European Medicines Agency (EMA) human medicines committee (CHMP) announced on March 11, 2021, the launch of a ‘rolling review’ of data on the antibodies bamlanivimab etesemivab being developed by Indiana-based Eli Lilly and Company.

A rolling review is a regulatory tool that EMA uses to speed up the assessment of a promising medicine or vaccine during a public health emergency.

The decision to start the rolling review is based on preliminary results from two studies, one looking at the ability of the medicines to treat COVID-19 when combined, the other one when bamlanivimab is used alone. Recent data shows antibody therapy reduced risk of hospitalizations and death by 87%

Bamlanivimab and etesemivab are two monoclonal antibodies with activity against COVID-19.

A monoclonal antibody is a type of protein that has been designed to attach to a specific structure (called an antigen). Bamlanivimab and etesemivab have been designed to attach to the spike protein of SARS-CoV-2 at two different sites. When they attach to the spike protein, the virus cannot enter the body’s cells. Because the antibodies attach to different parts of the protein, using them in combination may have a greater effect than either alone.

Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies to prevent and treat COVID-19.

Bamlanivimab is authorized in the USA to treat mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization.

Indianapolis-based Eli Lilly has for 140 years remained committed to his vision through every aspect of our business and the people we serve, starting with those who take our medicines, and extending to health care professionals, employees, and the communities which we live.