TPOXX® · Smallpox, monkeypox, cowpox, and complications from Vaccinia infection - treatment
New molecular entity
Development and Regulatory status
Jul 20 · 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).
Viral envelope protein (p37) inhibitor, inhibits extracellular viral replication.
Smallpox was a contagious, disfiguring disease which used to be a common cause of morbidity and mortality worldwide. Naturally-occurring smallpox has now been eradicated but ongoing interest in this disease lies both in the success of the eradication programme and in its potential as a biological weapon. [1,2]
Smallpox, monkeypox, cowpox, and complications from Vaccinia infection - treatment
Trial or other data
Jul 18 · FDA approval is based on extensive positive efficacy data in animal studies and human clinical safety data (n=700 human volunteers) without any drug-related serious adverse events. [2,3]
Aug 16 · Completion of PIII double-blind, placebo-controlled, randomised trial in 422 human volunteers that assessed the safety, tolerability and pharmacokinetics of oral tecovirimat 400mg or 600mg daily for 14 days in healthy volunteers (SIGA 246-008; NCT02474589). It was well tolerated and no serious adverse events observed.