EMA Panel Advises Against Use of Tecovirimat for Mpox Treatment

The European Medicines Agency’s human medicines committee, Committee for Medicinal Products for Human Use, has recommended that Tecovirimat SIGA should no longer be used to treat mpox in the European Union. However, its approved use for smallpox, cowpox, and vaccine-related complications remains unchanged.

The decision follows a review of four clinical trials—PALM007, STOMP, UNITY, and PLATINUM-UK—which showed that tecovirimat did not significantly improve outcomes. Patients receiving the drug did not experience faster healing of lesions, pain relief, or quicker viral clearance compared to placebo.

Initially authorised based on animal studies due to limited human data, the drug demonstrated benefits only when administered early after exposure. In real-world trials, treatment typically began later in the disease course, possibly reducing effectiveness.

No new safety concerns were identified. Patients already on treatment may complete their course, but new patients are advised not to start tecovirimat for mpox once the recommendation is finalized by the European Commission.

30-03-2026