US restricts use of two Covid-19 treatments ineffective against Omicron variant
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The monoclonal treatments, made by Eli Lilly and Regeneron, are no longer authorised for use in the US.
PHOTO: AFP
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WASHINGTON (BLOOMBERG) - US regulators have restricted the use of a pair of Covid-19 monoclonal antibody therapies after scientific evidence suggested they are unlikely to be effective against the Omicron variant.
The Food and Drug Administration (FDA) said in a statement on Monday (Jan 24) that it had decided to limit access to the treatments, which are made by Eli Lilly and Regeneron Pharmaceuticals, amid the recent surge in Omicron infections.
The variant, which was first detected last year in southern Africa, now accounts for nearly all new cases of Covid-19 in the United States.
"Because data shows these treatments are highly unlikely to be active against the Omicron variant, which is circulating at a very high frequency throughout the United States, these treatments are not authorised for use in any US states, territories and jurisdictions at this time," said Dr Patrizia Cavazzoni, director of the FDA's Centre for Drug Evaluation and Research.
As a result of the FDA's decision, the federal government will pause shipments of the drugs.
Monoclonal antibody therapies at one time were considered a pandemic-fighting breakthrough and characterised by top health officials as a bridge to vaccines before shots were available.
Regeneron's drug was given to former president Donald Trump when he contracted Covid-19 in October 2020.
The drugs are mainly used as a treatment for patients whose health conditions, age or weight place them at especially high risk of severe disease.
Another monoclonal antibody, made by GlaxoSmithKline and Vir Biotechnology, is believed to be effective against Omicron.
The decision to curtail access to the treatments was not entirely unexpected, as some virologists and infectious-disease experts had previously expressed concern that these were not likely to perform well against Omicron because of its mutations.
Omicron is now overwhelmingly the dominant strain in the US less than two months after it was first detected in California on Dec 1. The variant prompted a nationwide deluge of new cases, though there is now evidence that the rate of infections in some areas, including the north-east, is beginning to slow.
Meanwhile, supplies of new treatment options are ramping up.
The US last month started shipments of two Covid-19 pills - Pfizer's Paxlovid and another developed by Merck with Ridgeback Biotherapeutics - as well as a pre-exposure drug meant for those for whom vaccines are not effective.
