Eli Lilly monoclonal antibodies: stop of the review announced by EMA
Through its press release dated November 2, 2021, the European Medicines Agency (EMA) informed about the interruption of the continuous review for the therapy based on bamlanivimab and etesevimab, the monoclonal antibodies developed by the pharmaceutical company Eli Lilly .
It was the parent company that communicated to the EMA that it did not want to continue with the process necessary to obtain the authorization to market the therapy. Let’s see in more detail what the characteristics of Eli Lilly’s two monoclonal antibodies were and what will happen now.
Eli Lilly monoclonal antibodies: main characteristics
The two monoclonal antibodies developed by Eli Lilly are named bamlanivimab and etesevimab . Like other monoclonal antibodies, their purpose is to bind to the Spike protein of SARS-CoV-2 – the pathogen of COVID-19 – to prevent the latter from penetrating human cells. The therapy involves the joint administration of bamlanivimab and etesevimab by virtue of the ability to bind to the Spike in different sites.
The two monoclonal antibodies should have been given to COVID-19 patients over the age of 12 who did not require complementary oxygen. Eli Lilly’s antibody therapy has been subject to continuous review since March 2021. Please note that thanks to this tool, the manufacturer of a drug can provide the EMA’s Committee for Medicinal Products for Human Use (CHMP) with immediately available data from studies in progress. In March 2021, EMA had issued an initial recommendation in favor of the use of bamlanivimab and etesevimab in the EU even before the granting of the marketing authorisation.
Why did Eli Lilly make this decision?
By means of a communication sent to the EMA, Eli Lilly explained the reasons that led to this change of course as follows:
“Given the current demand from EU Member States, Lilly expects that no additional/new drug substance manufacturing campaigns will be needed for the foreseeable future. Therefore, at this point Lilly is unable to generate the additional data required by the CHMP to proceed with the formal MA application.”
The decisions of the EMA after the stop of Eli Lilly
Following Eli Lilly’s communication, EMA will stop analyzing the data and will not complete the ongoing review against the monoclonal antibodies bamlanivimab and etesevimab.
In a note, however, the EMA specified that Eli Lilly’s turnaround does not invalidate the recommendations issued in March 2021. It follows that patients treated with bamlanivimab and etesevimab will be able to continue the therapy, according to the provisions in force in the relevant EU country .
Eli Lilly can also ask for a new rolling review to be initiated against its antibody therapy. Alternatively, it can request marketing authorization on the basis of the data that has emerged up to now.
She defines herself as curious by nature. In 2006 she graduated with honors in Biotechnology at the Sapienza University of Rome. Between 2005 and 2009, she carried out a university internship and research activity in the field of tumor immunotherapy. She is a co-author of three scientific publications. Since 2007 you have associated your passion for science with that for the web, starting the management of the FitnessEquilibrium.com project.