SIGA - Public health officials defend requiring human tests for SIGA's Tpoxx for monkeypox

• A group of public health officials from several federal agencies penned an editorial in the New England Journal of Medicine defending a recent U.S. FDA statement that SIGA Technologies' ( NASDAQ: SIGA ) Tpoxx (tecovirimat) has not demonstrated efficacy in humans for monkeypox.
• The officials are from the FDA, CDC, and the National Institute of Allergy and Infectious Disease.
• Tpoxx is approved by the FDA as a smallpox treatment, but is available on a case-by-case basis under the agency's Expanded Access program for those who want it as a monkeypox treatment.
• The public health advisors say that Tpoxx's approval for smallpox was based under the "Animal Rule." That allows the FDA to give the green light to a drug based on animal testing only for a condition considered serious or life-threatening and for which conducting efficacy studies in humans is unethical.
• "In contrast to smallpox...researchers can design clinical trials [for monkeypox] that would be both ethical and feasible," the team wrote. "Animal studies may be compelling, but efficacy observed in animals does not always translate directly into efficacy observed in humans in subsequent clinical trials."
• They add that case reports of Tpoxx being used in patients with monkeypox is insufficient to demonstrate efficacy.
• "As was the case with antiretrovirals for HIV in the 1980s, without data from [randomized controlled trials], we will not know whether tecovirimat would benefit, harm, or have no effect on people with monkeypox disease."
• President Biden could declare monkeypox a national public health emergency as soon as Thursday, according to a report in The Washington Post .

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