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EMA Launches Review of Tecovirimat Effectiveness for Mpox

July 25, 2025

The European Medicines Agency’s review of Tecovirimat (TPOXX) marks a critical inflection point in the treatment of mpox. Once fast-tracked for emergency use, Tecovirimat’s approval was based on surrogate markers rather than demonstrated clinical efficacy. Now, new trial data from PALM007, STOMP, and UNITY trials show little to no advantage in healing time or symptom resolution, prompting a re-evaluation of its risk-benefit profile. As mpox continues to spread, particularly among high-risk populations, robust, evidence-based therapeutics are urgently needed. Regulators and public health agencies must ensure future responses are grounded in both science and transparency—not just speed.

The European Medicines Agency’s decision to initiate a formal review of Tecovirimat SIGA (TPOXX) reflects a growing concern over the drug’s clinical utility in treating mpox. Initially authorized under “exceptional circumstances” at the height of the 2022 outbreak in Europe, Tecovirimat was granted approval based primarily on pharmacokinetic and pharmacodynamic data, with no direct human efficacy trials. That gamble appears increasingly misaligned with the clinical evidence now emerging.

Data from the PALM007 trial in the Democratic Republic of the Congo, involving 597 participants with confirmed clade I mpox, revealed no significant improvement in lesion resolution time between the treatment and placebo groups. Similarly, the STOMP and UNITY trials—conducted across countries on patients with clade II mpox—also failed to show clinical benefit in terms of time to lesion healing. These findings are sobering for a disease that continues to challenge health systems across Africa and among marginalized communities in high-income countries.

While the initial rationale for emergency authorization is understandable—given mpox’s zoonotic nature and sporadic presentation—the lack of therapeutic efficacy in multiple randomized trials must now guide regulatory and clinical practice. The EMA’s review rightly underscores the importance of basing public health decisions on sound, peer-reviewed evidence. The current mpox burden, particularly among immunocompromised individuals and people living with HIV, demands effective and validated therapies—not unproven interventions.

Moving forward, this episode should serve as a cautionary tale. Rushing therapeutics into public stockpiles without rigorous validation not only risks patient outcomes but also undermines public trust. The global mpox response must now pivot toward funding and fast-tracking truly effective antivirals, like those still in clinical development, while revisiting global procurement strategies built on unconfirmed assumptions. For the communities most at risk, science—not expedience—must remain our North Star.

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