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US pauses shipments of Eli Lilly’s COVID-19 antibody treatment due to variant concerns

Laboratory analyses found the therapy was not effective against variants first discovered in South Africa and Brazil

The US has paused shipments of Eli Lilly’s COVID-19 antibody combination treatment after it was unable to show efficacy against variants first discovered in South Africa and Brazil.

The US Department of Health and Human Services (HHS) decided to halt shipments of the antibody cocktail – comprised of bamlanivimab and etesevimab – after laboratory analyses found the therapy was not effective against the variants.

The HHS also said, however, that antibody treatments from Regeneron (REGEN-COV) and GlaxoSmithKline (GSK) and Vir Biotechnology (sotrovimab) are ‘likely’ to be effective against these variants.

As such, the US Food and Drug Administration (FDA) has recommended that these two treatments be used in place of Eli Lilly’s antibody cocktail following the distribution pause.

In a statement to Reuters, Lilly said: "As variants continue to evolve and their patterns of transmission and prevalence shift, we will continue our work with governments and regulators worldwide to ensure our antibodies are available to appropriate patients.”

The distribution of the antibody combination treatment was also previously paused in nine states in the US after the frequency of COVID-19 variants grew,  specifically those identified first in Brazil and South Africa.

In April, the US Food and Drug Administration (FDA) revoked the emergency use authorisation for bamlanivimab alone, requiring that the antibody be administered only in combination with etesevimab.

Earlier this year, Lilly also cut its 2021 outlook after adjusting its forecast to reflect 'lower expected revenue' from its COVID-19 antibody sales.

During an earnings call, chief financial officer Anat Ashkenazi said the company is “narrowing” its range for COVID-19 antibody revenue, from the previously forecasted $1bn to $2bn to the newly adjusted $1bn to $1.5bn. In Q1, the total revenue for Lilly’s COVID-19 antibodies was $650.6m in the US and $159.5m elsewhere.

As a result, Lilly also reduced its full-year forecast by approximately $400m to a projected 2021 revenue of between $26.6bn and $27.6bn.

“Based on the rollout of the vaccine across major markets, current antibody utilisation rate, existing US government bamlanivimab supply and the transition to only supply bamlanivimab and etesevimab administered together in the US, we believe this update range contemplates a variety of potential scenarios,” said Ashkenazi.

Article by
Lucy Parsons

28th June 2021

From: Sales

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