FDA Halts Use of Two Treatments Ineffective Against Omicron

(Bloomberg) -- U.S. regulators 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 said in a statement on Monday that it had decided to limit access to the treatments, which are made by Eli Lilly & Co. and Regeneron Pharmaceuticals Inc., 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 U.S. 

“Because data show 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 authorized for use in any U.S. states, territories, and jurisdictions at this time,” said Patrizia Cavazzoni, director of the FDA’s Center 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 characterized 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 Plc and Vir Biotechnology Inc., is believed to be effective against omicron.

Evasive Mutations

The decision to curtail access to the treatments wasn’t entirely unexpected, as some virologists and infectious-disease experts had previously expressed concern that they weren’t likely to perform well against omicron because of its mutations. 

Omicron is now overwhelmingly the dominant strain in the U.S. 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 Northeast, is beginning to slow.

Meanwhile, supplies of new treatment options are ramping up. The U.S. last month started shipments of two Covid-19 pills -- Pfizer’s Paxlovid, and another developed by Merck & Co with Ridgeback Biotherapeutics LP -- as well as a pre-exposure drug meant for those for whom vaccines aren’t effective.

Florida Use

Health officials continue to urge people to get vaccinated to lower their chances of severe Covid-19, but have pointed to the availability of treatments in distinguishing the current surge in cases from earlier waves of the pandemic.

Florida Governor Ron DeSantis has been slow to back away from certain monoclonal antibody treatments despite evidence that not all of them work against omicron. DeSantis, like many other Republicans, has emphasized the monoclonals as surveys showed entrenched vaccine hesitancy among some voters. 

Just last week, the Florida Department of Health announced the opening of five new state monoclonal antibody treatment sites, in a press release that specifically touted DeSantis’s efforts to secure more Regeneron drugs for the state. On Jan. 5, DeSantis told reporters that “with omicron, there’s not enough evidence” that the Regeneron and Lilly therapies aren’t effective. The governor’s press office didn’t immediately respond to a request for comment.

In the most recent week, the U.S. distributed 225,590 courses of therapeutics, including 55,224 of Regeneron’s Regen-Cov antibody therapy and 44,550 of Lilly’s antibody cocktail, according to Department of Health and Human Services data.

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