EMA reviewing data on four COVID monoclonal antibodies

Regulatory NewsRegulatory News | 04 February 2021 |  By 

The European Medicines Agency (EMA) on Thursday announced its Committee for Medicinal Products for Human Use (CHMP) is reviewing data on the use of two monoclonal antibody combinations developed by Regeneron and Eli Lilly to treat patients with COVID-19 who are at high risk of progressing to severe disease but who do not require supplemental oxygen.
EMA says the committee will conduct two separate reviews, one of Regeneron’s antibody combination known as REGN-COV2 (casirivimab/imdevimab) and one of Eli Lilly’s bamlanivimab/etesevimab cocktail, in light of recent studies that found the antibody cocktails reduced viral loads and led to fewer hospitalizations compared to placebo. The agency will also look at the use of bamlanivimab on its own. The procedures, conducted under Article (5)(3) of Regulation (EC) No 726/2004, will allow the agency to provide a harmonized scientific opinion on the use of the antibodies to support decisions on their use at the national level in the EU before they are formally authorized.
The Article 5(3) procedure was also used to endorse the use of the corticosteroid dexamethasone to treat hospitalized COVID-19 patients who require oxygen therapy. In the case of dexamethasone, the drug was already authorized on the national level in the EU.
For both antibody combinations and dexamethasone, the Article 5(3) review was initiated at the request of EMA’s executive director following discussions with the COVID-19 EMA pandemic task force.
The announcement comes just days after EMA announced it had kicked off a rolling review of REGN-COV2 based on preliminary data showing the antibodies reduced the amount of virus present in the nose and throat of non-hospitalized patients with COVID-19. While the rolling review may eventually yield a positive recommendation for an EU-wide marketing authorization, the Article 5(3) reviews could provide EU member states advice on the use of COVID-19 antibodies in a shorter timeframe.
EMA is not currently reviewing bamlanivimab/etesevimab outside of the Article 5(3) procedure and the agency has so far not recommend the use of any monoclonal antibodies for COVID-19. Across the Atlantic, the US Food and Drug Administration (FDA) has already granted an emergency use authorization (EUA) for the Regeneron combination as well as for bamlanivimab.


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy