The Ministry of Health (MH) sent Brazilian National Health Surveillance Agency (Anvisa) a request for exemption from the sanitary registration, on an exceptional and temporary basis, of the drug Tecovirimat concentration 200 mg, capsule, oral use, for the treatment of Monkeypox, due to the public health emergency of international importance. The drug will be acquired by the MH by donation from the company SIGA Technologies and is manufactured by Catalent Pharma Solutions, located in the United States.
The MH also forwarded, together with its request, the assessment reports from the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) of the drug Tecovirimat SIGA, the package insert, as well as the labeling words. In addition, the MH forwarded to ANVISA the summary opinion of authorization for use from the EMA, certificate of batch quality control analysis, inspection report of the production site issued by the FDA, instructions for use of the drug and related scientific articles. It is important to note that Tecovirimat was evaluated both by the regulatory authorities of the United States and Europe (FDA and EMA – agencies considered as reference by ANVISA) and received authorization to be used in the respective target populations of each country.
In the US, the drug Tecovirimat (trade name TPOXX) from the company SIGA Technologies has been approved since 2018 for the treatment of adult and child patients with smallpox disease caused by the smallpox virus. However, to date, the FDA has not evaluated the safety and efficacy aspects of Tecovirimat for the treatment of Monkeypox, but the US Centers for Disease Control and Prevention (CDC) maintains an expanded access protocol for new investigational drugs, which allows the use of the drug TPOXX (Tecovirimat) for the primary or early empirical treatment of non-pox orthopoxvirus infections, including Monkeypox, in adults and children of all ages.
In Europe, the EMA granted, in January 2022, a marketing authorization for Tecovirimat SIGA valid throughout the European Union for the treatment of smallpox, Monkeypox and cowpox. The European Agency indicated that Tecovirimat is effective in reducing mortality caused by smallpox, Monkeypox and cowpox, based on animal studies. This drug has been evaluated in uninfected people, but its side effects are expected to be similar in infected people and are considered acceptable. The EMA has therefore indicated that the benefits of Tecovirimat SIGA are greater than its risks and it can be authorized for use in the European Union.
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