{"id":41558,"date":"2021-11-30T07:21:04","date_gmt":"2021-11-30T07:21:04","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=41558"},"modified":"2021-11-30T14:49:45","modified_gmt":"2021-11-30T14:49:45","slug":"eli-lilly-withdraw-eu-applications-for-bnabs-etesevimab-and-bamlanivimab","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/41558","title":{"rendered":"Eli Lilly withdraw EU application for bNAbs etesevimab and bamlanivimab"},"content":{"rendered":"
\n

Simon Collins, HIV i-Base<\/strong><\/p>\n<\/div>\n

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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announced that the current EU application for the dual bNAbs etesevimab and bamlanivimab against COVID-19 would be withdrawn.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]<\/span><\/strong><\/p>\n<\/div>\n

\n

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.<\/span><\/p>\n<\/div>\n

\n

In response, the EMA have stopped the rolling review of these bNAbs. [2]<\/span><\/p>\n<\/div>\n

\n

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]<\/span><\/p>\n<\/div>\n

\n

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.<\/span><\/p>\n<\/div>\n

\n

The EMA are currently reviewing an application for the dual bNAbs casirivimab and imdevimab developed by Regeneron. [4]<\/span><\/p>\n

comment<\/h3>\n

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]<\/strong><\/p>\n

The Regeneron bNAbs are now routinely available in the UK in selected cases in the UK based on risk of COVID-19 progression. [6]<\/strong><\/p>\n

References<\/span><\/p>\n<\/div>\n

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

    This report was first published on 3 November 2021.<\/em><\/p>\n<\/div>\n

    \n

    \u00a0<\/span><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

    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 …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[283,278],"tags":[],"class_list":["post-41558","post","type-post","status-publish","format-standard","hentry","category-covid-19-investigational-drugs","category-covid-19"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/41558","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=41558"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/41558\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=41558"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=41558"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=41558"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}