(Bloomberg) — The Food and Drug Administration is poised to halt use of two monoclonal antibody therapies that are believed to be ineffective against the omicron variant, according to people familiar with the matter, a move that will lead the federal government to pause shipments of the treatments to states.
The drugs, from Eli Lilly & Co. and Regeneron Pharmaceuticals Inc., aren’t believed to help when patients are infected with omicron, which is the overwhelmingly dominant strain in the U.S. Another monoclonal antibody, sotrovimab from GlaxoSmithKline Plc and Vir Biotechnology Inc., is believed to be effective.
The FDA change is expected imminently, according to the people, who spoke on the condition of anonymity ahead of an announcement. One of the people said the agency would say the therapies aren’t authorized for use at this time. The FDA declined to comment. The news was reported earlier by the Washington Post.
Regneron shares fell 0.4% at 3:50 p.m. in New York, while Lilly’s dipped 0.2%.
Meanwhile, supplies of new treatment options are ramping up. The U.S. last month started shipments of two Covid-19 pills — Pfizer Inc.’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
The pair of treatments from Eli Lilly and Regeneron were hailed as breakthroughs earlier in the pandemic, but mutations present in the omicron variant have largely sidelined them. 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.
(Updates with shares in fourth paragraph, current use of therapies in final three)
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