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November 3, 2021

EMA stops rolling review of Lilly’s antibodies for Covid-19

Lily stated that the lack of requirements for additional therapies in the EU led to the withdrawal of application for antibodies.

The European Medicines Agency (EMA) has ended the rolling review of the marketing authorisation application for Eli Lilly Netherlands’ antibodies, bamlanivimab and etesevimab, to treat Covid-19.

The move comes after the company withdrew from the process saying there is no requirement for new or additional manufacturing campaigns for drugs in the future based on the existing demand from member states of the EU.

These monoclonal antibodies are intended for Covid-19 patients aged 12 years and above who do not need supplemental oxygen and are at high risk of disease progression.

The human medicines committee (CHMP) of the EMA was assessing the data on the cocktail therapy under a rolling review process, since March.

As part of the review, the company submitted the information when it became available, to expedite the assessment for obtaining marketing authorisation.

The agency had received a non-clinical, clinical trial and quality and manufacturing process data of the combination therapy and the risk management plan when the application was withdrawn.

With the latest development, the EMA noted that it will not further examine the data on the antibodies and the review will not be completed.

Lilly is open to seeking another rolling review in the future or filing an application to obtain marketing authorisation in the EU.

The antibodies bamlanivimab and etesevimab will bind to the spike protein of the SARS-CoV-2 virus at two different sites, stopping the virus from entering the body’s cells.

In September, Lilly signed a joint procurement deal with the European Commission to deliver up to 220,000 doses of the products for Covid-19 treatment.

The deal allows participating EU and European Economic Area (EEA) countries to purchase the antibodies from Lilly directly, once they receive emergency use approval or marketing authorisation at the EU level.

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