EU - EMA's Emergency Task Force acknowledges loss of activity of mAbs against COVID-19 emerging variants and recommends Paxlovid & Veklury

The EMA's Emergency Task Force (ETF) has released a statement ackowledging that the use of monoclonal antibodies (mAbs) for the prevention or treatment of COVID-19 in patients at increased risk for progressing to severe COVID-19 will likely not provide a clinical benefit in regions of the EU in which BQ.1.1, BQ.1, BA.4.6, BA.2.75.2, XBB and BJ.1 are spreading.

The ETF also added that it remains unknown to what extent the approved monoclonal antibodies that have decreased neutralisation activity against the Omicron sublineages BA.1, BA.2, BA.4 and BA.5 will be clinically effective.

The ETF advised healthcare professionals to check the current epidemiological situation in their region and to consider alternative antiviral treatment options like Paxlovid (Nirmatrelvir/Ritonavir) and Veklury (remdesivir) that are approved in the EU for the treatment of COVID-19 in patients who are at increased risk for progressing to severe COVID-19 and do not require supplemental oxygen. These therapies are expected to retain their antiviral activity against the emerging variants of concern, as their activity has not been affected so far by the mutational pattern of currently circulating variants of concern.

As a reminder, 4 mAbs are currently approved in the EU for the treatment and prevention of COVID-19: Astrazeneca's Evusheld (tixagevimab/cilgavimab), Roche's Ronapreve (casirivimab / imdevimab), GSK's Xevudy (sotrovimab) and Celltrion's Regkirona (regdanvimab).

For additional information https://www.ema.europa.eu/en/news/etf-warns-monoclonal-antibodies-may-not-be-effective-against-emerging-strains-sars-cov-2