In a much-anticipated draft guidance issued on Thursday, the US Food and Drug Administration (FDA) said that unlike smallpox therapeutics, treatments for mpox cannot be developed under the Animal Rule, which enables the agency to approve products without human clinical trials in limited circumstances.
The agency also said that sponsors should talk to regulators early to discuss appropriate clinical trial designs and metrics to prove safety and efficacy. The guidance does not apply to the development of preventative vaccines for mpox, which “raise different and additional considerations,” FDA said.
An unprecedented outbreak of mpox was first identified in May 2022 that impacted parts of Europe, North and South America, and other parts of the world outside of Central and West Africa, where the disease is endemic. At its peak, the US was seeing upwards of 400 cases per day, though cases have fallen sharply in recent months, according to the Centers for Disease Control and Prevention (CDC)…
