Eli Lilly withdraw EU application for bNAbs etesevimab and bamlanivimab

Simon Collins, HIV i-Base

On 29 October 2021, Eli Lilly announced that the current EU application for the dual bNAbs etesevimab and bamlanivimab against COVID-19 would be withdrawn. [1]

This was based on low level demand for these compounds, which would also limit to collect further data that was requested as part of the application.

In response, the EMA have stopped the rolling review of these bNAbs. [2]

However, the US Government has invested more than $1.3 billion in acquiring stocks of etesevimab and bamlanivimab for treatment and prophylaxis of COVID-19. [3]

This is covered in the US by emergency use authorisation in people 12 years and above with mild-to-moderate COVID-19 at high risk for progression.

The EMA are currently reviewing an application for the dual bNAbs casirivimab and imdevimab developed by Regeneron. [4]

comment

Part of the limited demand for bamlanivimab might likely be due to lack of activity against the Delta variant, when used as a single bNAb. [5]

The Regeneron bNAbs are now routinely available in the UK in selected cases in the UK based on risk of COVID-19 progression. [6]

References

1. Eli Lilly. Bamlanivimab(EMEA/H/C/005836/0000) and Etesevimab (EMEA/H/C/005837/0000). Letter. (29 October 2021).
   https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-bamlanivimab-etesevimab_.pdf (PDF)
2. EMA. EMA ends rolling review of the antibodies bamlanivimab and etesevimab for COVID-19 following withdrawal by Lilly. (2 November 2021).
   https://www.ema.europa.eu/en/news/ema-ends-rolling-review-antibodies-bamlanivimab-etesevimab-covid-19-following-withdrawal-lilly
3. Eli Lilly. Lilly to supply 614,000 additional doses of bamlanivimab and etesevimab to the U.S. Government for the treatment or post-exposure prevention of COVID-19. (2 November 2021).
   https://investor.lilly.com/news-releases/news-release-details/lilly-supply-614000-additional-doses-bamlanivimab-and-etesevimab
4. EMA. EMA receives application for marketing authorisation for Ronapreve (casirivimab / imdevimab) for treatment and prevention of COVID-19. (11 October 2021).
   https://www.ema.europa.eu/en/news/ema-receives-application-marketing-authorisation-ronapreve-casirivimab-imdevimab-treatment
5. Coronavirus (COVID-19) update: FDA revokes emergency use authorization for monoclonal antibody bamlanivimab. )16 April 2021).
   https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-monoclonal-antibody-bamlanivimab
6. MHRA. Casirivimab and imdevimab for patients hospitalised due to COVID-19. (17 September 2021).
   https://www.cas.mhra.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=103175

This report was first published on 3 November 2021.