European Medicines Agency Reviews Tecovirimat for Effectiveness

The European Medicines Agency (EMA) has initiated a review of Tecovirimat, a drug used to treat infections caused by various Orthopoxviruses, including the Mpox virus. This review follows concerns over the drug's effectiveness in treating Mpox, which was formerly known as the monkeypox virus.

Tecovirimat, marketed as Siga®, received European Union approval in 2022 to treat Mpox, smallpox, and cowpox in both adults and children weighing at least 13 kilograms. However, this approval was granted under 'exceptional circumstances' due to the lack of sufficient efficacy data at the time. Since then, Siga Technologies, the manufacturer, has been required to submit annual reports detailing the benefits and risks associated with the medication.

Recent clinical studies, including the PALM007 and STOMP trials, have raised significant questions about the drug's efficacy against Mpox. Preliminary results from the UNITY study have also suggested that patients infected with the Mpox virus do not experience faster healing of skin lesions when treated with Tecovirimat compared to those receiving a placebo. Despite these concerns, the EMA has indicated that no new safety issues have emerged regarding the drug, with common side effects remaining headaches and nausea.

The Committee for Medicinal Products for Human Use (CHMP) at the EMA will thoroughly evaluate all available data on Tecovirimat's effectiveness and safety. This investigation will include findings from ongoing studies such as PLATINUM-CAN, PLATINUM, and EPOXI, alongside the previously mentioned trials.

As the review progresses, the EMA will determine whether Tecovirimat should continue to be authorized for use in treating Mpox and related infections, based on the latest evidence.