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EMA ended rolling review of bamlanivimab and etesevimab developed by Elli Lilly Netherlands

Christian Fernsby |
EMA has ended the rolling review of bamlanivimab and etesevimab, two antibodies for the treatment of COVID-19 developed by Elli Lilly Netherlands BV, after the company informed the Agency that it was withdrawing from the process.

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Since March 2021, EMA’s human medicines committee (CHMP) has been reviewing data on these medicines as part of a rolling review. During this process the company submitted data as they became available in order to speed up the evaluation of an eventual marketing authorisation application.

In March 2021, EMA also issued advice for treating COVID-19 based on data from a clinical study. This advice supported the use of the antibodies at national level before a marketing authorisation.

At the time of the company’s withdrawal, EMA had received non-clinical (laboratory) data, data from clinical studies, data on the quality and manufacturing process of the antibodies and the risk management plan (RMP).

Although EMA was speeding up its review of the data, some questions about the medicines’ quality remained to be satisfactorily addressed.

The withdrawal was a decision by the company and the reasons can be found in the company’s PDF icon letter of withdrawal.

This means that EMA is no longer reviewing data on these antibodies and will not conclude this review. The company retains the right to request another rolling review or submit a marketing authorisation application in the future.

The withdrawal has no consequences on the previous advice issued in March and patients may continue to receive the medicines based on national arrangements.


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