The European Medicines Agency (EMA) is recommending that the antiviral drug tecovirimat (Tpoxx) no longer be used for treating mpox, after studies found it essentially useless for this particular virus, reports CIDRAP News.
The recommendation, made by the EMA’s Committee for Medicinal Products for Human Use, is based on four studies that have found Tpoxx was no better than a placebo to heal active mpox lesions, relieve pain, or help clear the virus faster.
The EMA had authorised it as a treatment for the disease back in November 2021, but noted last week that the approval had been based on an animal model of infections, as the virus was not circulating widely enough in people at the time to conduct human studies.
“The animal data demonstrated antiviral activity and a survival benefit when treatment was started early and a reduced efficacy if treatment were initiated later after exposure to the virus,” it said in a statement.
That was before the clade 2 outbreaks began in 2022, after which the World Health Organisation (WHO) declared mpox a Public Health Emergency of International Concern (PHEIC), enabling drugmaker SIGA Technologies to conduct efficacy studies in people.
The WHO declared a second PHEIC in 2024 over clade 1 outbreaks.
The EMA says the recommendation doesn’t apply to authorised use of Tpoxx for smallpox, cowpox, and complications from smallpox vaccines.
Most mpox cases in Africa
Meanwhile, the WHO said in an outbreak update last week that 1 184 confirmed mpox cases and four deaths were reported in 46 countries across all WHO regions in February. Of these cases, 58.6% were reported in Africa.
The countries reporting the most cases over the past six weeks are Madagascar, the Democratic Republic of the Congo, Kenya, Burundi, and Liberia.
The WHO said all clades continue to circulate, and transmission of the virus continues mostly within sexual networks, followed by household transmission. All age-groups in some historically endemic areas are being affected.
“Unless mpox outbreaks are rapidly contained and human-to-human transmission is interrupted, there is a risk of sustained community transmission in all settings,” the WHO said.
See more from MedicalBrief archives:
Japan approves mpox drug that failed two efficacy trials
Hope for Africa as WHO approves first mpox vaccine
Madagascar reports first mpox death
WHO ends mpox public health emergency, Africa CDC extends it