As omicron potentially threatens monoclonal therapies efficacy, FDA health panel endorses first at-home COVID-19 treatment pill

Posted at 5:31 PM, Nov 30, 2021
and last updated 2021-11-30 18:42:22-05

TAMPA, Fla. — As omicron sounds the alarm as a new variant of concern, Regeneron announced it is now re-evaluating its monoclonal antibody treatment.

“If omicron becomes the dominant strain in the United States, the monoclonal antibody therapies that we have right now will not be effective,” said Dr. Michael Teng, an associate professor of Medicine at USF.

He said that’s because early data seems to show mutations in the spike proteins.

This is one of the really concerning things about omicron. It does have mutations that have been found in the lab to provide resistance to all of the monoclonals that we use,” he said.

The vaccine gives people immunity to those proteins but for those who are not vaccinated, the monoclonal therapy injects antibodies to help fight against those proteins.

The Monoclonal antibodies are basically giving you an immune system, manufactured immune system rather than using your own immune system,” said Dr. Teng.

But, Teng said the monoclonal drugs being used right now only have two antibodies aimed at attacking certain spike proteins. If the proteins change, the virus won’t be neutralized by the antibodies anymore.

Regeneron said it has been working on several “next-generation antibodies” that may have the potential to “retain activity against the omicron variant, as well as other existing variants of concern.” It said it will have more data over the next month.

Meanwhile, a new at-home pill called Molnupiravir is being considered by the FDAthat is 30% effective at preventing hospitalizations in COVID-infected patients. It’s taken twice daily for five days within five days of symptom onset.

“It’s a little drug that goes in and it blocks one of the viral processes, so it actually goes into the cell that’s infected, it prevents the virus from making more of itself,” Dr. Teng said.

Some think that could help create a more severe strain of the virus, but FDA regulators think that is theoretical and unlikely. Molnupiravir, at the moment, is not recommended in women who are pregnant or are breastfeeding.

Pfizer has a similar drug awaiting FDA emergency use authorization that has a 90% efficacy in preventing hospitalizations. Right now, Dr. Teng said it seems those drugs do seem to work against Omicron.