dm+d

Unassigned

New Medicines

TPOXX® Smallpox, monkeypox, cowpox, and complications from Vaccinia infection - treatment

Information

TPOXX®
New molecular entity
SIGA Technologies
SIGA Technologies

Development and Regulatory status

Pre-registration (Filed)
Pre-registration (Filed)
Approved (Licensed)
Jul 20Filed in EU via centralised procedure for treatment of smallpox, monkeypox, cowpox, and complications from Vaccinia infection [4].

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.[3]


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).[3]

Category

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
Oral

Trial or other data

Jul 18FDA 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 16Completion 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.[3]