As monkeypox cases continue to rise in the U.S. and the rest of the world, many of those most affected by the virus say they cannot access effective treatment.
An antiviral drug called tecovirimat, or TPOXX, is already approved by the U.S. Food and Drug Administration for treating smallpox and can also be used with monkeypox—a related virus. But the only U.S. supply of this drug is in the country’s Strategic National Stockpile, and the Centers for Disease Control and Prevention requires that health care providers submit an investigational new drug, or IND, application in order to access it for their patients. Critics say the process for obtaining an IND for TPOXX is burdensome, however, and that the drug—which was originally tested in animals with monkeypox—should be more readily available for treating the disease in people.
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“The TPOXX issues, from a scientific perspective, make zero sense,” says gay rights activist James Krellenstein, co-founder and managing director for strategy and policy at PrEP4All, an organization working to increase access to HIV medication. “TPOXX was approved on animal data [for monkeypox],” he says. But the CDC’s position is that “you can’t prescribe [the] drug … for monkeypox because the FDA label says, ‘Only smallpox.’”
