WHO Recommends Against Roche, GSK's COVID-19 Therapies Rendering Them Obsolete

Zinger Key Points
  • Lab tests suggests the two therapies have limited clinical activity against omicron variants.
  • With WHO's recommendation, question arises on how many other countries will follow.

Due to the lack of effectiveness against omicron and the variants, World Health Organization (WHO) no longer recommends using two COVID-19 antibody therapies.

WHO experts said they strongly advised against using GSK plc GSKVir Biotechnology Inc's VIR sotrovimab and Regeneron Pharmaceuticals Inc REGNRoche Holdings AG's RHHBY antibody cocktail casirivimab-imdevimab.

The recommendation comes as part of a suite of recommendations published in the British Medical Journal.

The two therapies designed to work by binding to the spike protein of SARS-CoV-2 to neutralize the virus were some of the first medicines developed early in the pandemic.

For both therapies, WHO said that although previous clinical trial evidence remains accurate, the panel concluded that it is no longer applicable following the emergence of currently circulating SARS-CoV-2 variants and subvariants (such as omicron) now dominating covid-19 worldwide. 

Evidence shows that the therapies lack in vitro neutralization activity. Evidence of clinical effectiveness does not exist.

In April, FDA said sotrovimab antibody therapy was no longer authorized as a COVID-19 treatment.

Recently, the companies said they do not plan to file a marketing application to the FDA for sotrovimab for COVID-19.

The FDA has extended its review of the casirivimab imdevimab cocktail, dubbed REGEN-COV, for non-hospitalized COVID-19 patients and as prophylaxis in certain individuals, with a decision expected on 13 July. However, there was no update on the application.

REGEN-COV did not generate any sales in the U.S. in Q1 and Q2 FY22 after the company completed its final deliveries under its agreements with the U.S. government.

Price Action: REGN shares are up 0.65% at $710.47, GSK stock is down 0.48% at $30.87, and VIR shares are down 1.43% at $20.02 on the last check Friday.

Photo Credit: Miguel Á. Padriñán by Pexels and Wikipedia

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