EMA’s committee for human medicines, CHMP, has recommended that Tecovirimat SIGA should no longer be used for the treatment of mpox. This recommendation does not affect the other authorised uses of Tecovirimat SIGA, which include the treatment of smallpox, cowpox and complications from smallpox vaccines.

Mpox is a viral infection that typically starts with fever, swollen lymph nodes and muscle aches, followed by a painful rash with fluid-filled lesions. While most cases are mild and resolve without complications, mpox can lead to more serious illness in children, pregnant people and those with a weakened immune system.

The CHMP’s recommendation for mpox follows a review of data from four studies carried out in different regions, which showed that treatment with Tecovirimat SIGA did not heal lesions faster compared with placebo (a dummy treatment) in people presenting with active mpox lesions (PALM007, STOMP, UNITY and PLATINUM-UK). The findings of these studies also showed…