Available in the UK. A rapid policy statement published on 20 September 2022 by the four UK governments, says that hospitalised patients weighing 13kg ore more with PCR-confirmed monkey pox are eligible for antiviral treatment with tecovirimat if they have one or more criteria for severe or complicated disease. These criteria include intractable pain, neurological problems, immunodeficiency or extensive cutaneous disease. Supply is being managed by specialist regional adult infectious centres .
Approved in UK for the treatment of smallpox, monkeypox, cowpox, and vaccinia complications following vaccination against smallpox in adults and children with a body weight of at least 13kg .
Approved in the EU [6
Recommended for EU approval, under exceptional circumstances, by CHMP “for the treatment of smallpox, monkeypox and cowpox in adults and children with body weight at least 13 kg, and to treat complications due to replication of vaccinia virus following vaccination against smallpox, in adults and children with body weight at least 13 kg. Tecovirimat SIGA should be used in accordance with official recommendations”. Tecovirimat SIGA will be available as 200 mg hard capsules .
Filed in EU via centralised procedure for treatment of smallpox, monkeypox, cowpox, and complications from Vaccinia infection .
Jul 18: US FDA approves tecovirimat for the treatment of Smallpox.[2,3]
May 18: FDA´s Antimicrobial Drugs Advisory Committee adopts a positive opinion for the use of tecovirimat for Smallpox.
Dec 17: Filed for approval. FDA assigns target final action date of Aug 18 (priority review under the Material Threat Countermeasure PRV program enacted by the 2016 21st Century Cures Act).