Feds may limit authorizating monoclonal antibody treatments

According to a source familiar with the decision-making, US regulators are considering limiting the authorization of certain monoclonal antibody treatments for COVID-19 that have not proved effective against the Omicron variant, reported CNN.

The FDA could decide in the coming days to take steps to curb the use of antibody treatments produced by Eli Lilly and Regeneron Pharmaceuticals, the source said, pointing to the growing body of evidence that shows their monoclonal therapies do not effectively neutralize Omicron.

The US National Institutes of Health had (NIH) recently updated its guidelines to advise clinics against using these treatments on patients with mild-to-moderate COVID-19 due to their diminished effectiveness against the highly contagious variant.

Senior health officials, including David Kessler, chief science officer of the White House's COVID Response Team, and assistant secretary for Health Rachel Levine, recently urged governors and state health officials against using these treatments, with Omicron now accounting for nearly all positive cases, a source familiar with the matter said.

However some states continue to push them despite the recent data. Over the last two weeks, states have distributed nearly 110,000 doses of the Eli Lily and Regeneron treatments, according to a federal database maintained by the Health and Human Services department.

The Biden administration has pushed for states to pivot to other treatments that show greater effectiveness against Omicron, including antiviral pills by Pfizer and Merck & Co., GlaxoSmithKline's monoclonal antibody, AstraZeneca's pre-exposure prophylaxis, and Gilead Sciences' antiviral Veklury (remdesivir).