Tecovirimat

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Tecovirimat
Tecovirimat.svg
Clinical data
Trade namesTpoxx
Other namesST-246
AHFS/Drugs.comMonograph
Routes of
administration		By mouth
ATC code
Legal status
Legal status
Identifiers
  • N-{3,5-Dioxo-4-azatetracyclo[5.3.2.0{2,6}.0{8,10}]dodec-11-en-4- yl}-4-(trifluoromethyl)benzamide
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
ChEMBL
Chemical and physical data
FormulaC19H15F3N2O3
Molar mass376.335 g·mol−1
3D model (JSmol)
  • FC(F)(F)c1ccc(cc1)C(=O)NN1C(=O)C2C(C3C=CC2C2CC32)C1=O
  • InChI=1S/C19H15F3N2O3/c20-19(21,22)9-3-1-8(2-4-9)16(25)23-24-17(26)14-10-5-6-11(13-7-12(10)13)15(14)18(24)27/h1-6,10-15H,7H2,(H,23,25) checkY
  • Key:CSKDFZIMJXRJGH-UHFFFAOYSA-N checkY

Tecovirimat, sold under the brand name Tpoxx,[2] is an antiviral with activity against orthopoxviruses such as smallpox and monkeypox. It was the first antipoxviral drug approved in the United States.[3]

The drug works by blocking cellular transmission of the virus, thus preventing the disease.[4] Tecovirimat has been effective in laboratory testing; it has been shown to protect animals from monkeypox and rabbitpox and causes no serious side effects in humans.[2] However, tecovirimat has never been used to treat a human with smallpox due to the disease's eradication.

Two million doses of tecovirimat are stockpiled in the US Strategic National Stockpile should an orthopoxvirus-based bioterror attack occur.[5][6]

The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[7]

Clinical study[]

The results of clinical trials involving tecovirimat support its use against smallpox and other related orthopoxviruses. It has shown potential for a variety of uses including preventive healthcare, as a post-exposure therapeutic, as a therapeutic and an adjunct to vaccination.[8]

Tecovirimat can be taken orally and has recently been permitted for Phase II trials by the U.S. Food and Drug Administration (FDA). In Phase I trials, tecovirimat was generally well tolerated with no serious adverse events.[9] Due to its importance for biodefense, the FDA has designated tecovirimat for 'fast-track' status, creating a path for expedited FDA review and eventual regulatory approval. On 13 July 2018, the FDA announced approval of tecovirimat.[10]

Mechanism of action[]

Tecovirimat inhibits the function of a major envelope protein required for the production of extracellular virus. The drug prevents the virus from leaving an infected cell, hindering the spread of the virus within the body.[11]

Use[]

Tecovirimat was first used for treatment in December 2018, after a laboratory-acquired vaccinia virus infection.[12]

Society and culture[]

Originally researched by the National Institute of Allergy and Infectious Diseases, the drug was previously owned by Viropharma and discovered in collaboration with scientists at USAMRIID. It is currently[when?] owned and manufactured by Siga Technologies, a pharmaceutical company in the biodefense arena that won a government contract to develop the drug.

Legal status[]

In November 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization under exceptional circumstances for the medicinal product Tecovirimat SIGA, intended for the treatment of orthopoxvirus disease (smallpox, monkeypox, cowpox, and vaccinia complications).[13] The applicant for this medicinal product is SIGA Technologies Netherlands B.V.[13]

References[]

  1. ^ "U.S. Food and Drug Administration Approves SIGA Technologies' TPOXX (tecovirimat) for the Treatment of Smallpox - SIGA". SIGA.
  2. ^ a b McNeil Jr DG (13 July 2018). "Drug to Treat Smallpox Approved by F.D.A., a Move Against Bioterrorism". The New York Times. Retrieved 16 July 2018.
  3. ^ "FDA approves the first drug with an indication for treatment of smallpox". U.S. Food and Drug Administration (FDA) (Press release). 13 July 2018. Retrieved 1 August 2018.
  4. ^ Grosenbach DW, Honeychurch K, Rose EA, Chinsangaram J, Frimm A, Maiti B, et al. (July 2018). "Oral Tecovirimat for the Treatment of Smallpox". The New England Journal of Medicine. 379 (1): 44–53. doi:10.1056/NEJMoa1705688. PMC 6086581. PMID 29972742.
  5. ^ Damon IK, Damaso CR, McFadden G (May 2014). "Are we there yet? The smallpox research agenda using variola virus". PLOS Pathogens. 10 (5): e1004108. doi:10.1371/journal.ppat.1004108. PMC 4006926. PMID 24789223.
  6. ^ Cunningham A (13 July 2018). "FDA approves the first smallpox treatment".
  7. ^ New Drug Therapy Approvals 2018 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2019. Retrieved 16 September 2020.
  8. ^ Siga Technologies
  9. ^ Jordan R, Tien D, Bolken TC, Jones KF, Tyavanagimatt SR, Strasser J, et al. (May 2008). "Single-dose safety and pharmacokinetics of ST-246, a novel orthopoxvirus egress inhibitor". Antimicrobial Agents and Chemotherapy. 52 (5): 1721–7. doi:10.1128/AAC.01303-07. PMC 2346641. PMID 18316519.
  10. ^ Commissioner, Office of the (24 March 2020). "Press Announcements - FDA approves the first drug with an indication for treatment of smallpox". U.S. Food and Drug Administration (FDA).
  11. ^ Yang G, Pevear DC, Davies MH, Collett MS, Bailey T, Rippen S, et al. (October 2005). "An orally bioavailable antipoxvirus compound (ST-246) inhibits extracellular virus formation and protects mice from lethal orthopoxvirus Challenge". Journal of Virology. 79 (20): 13139–49. doi:10.1128/JVI.79.20.13139-13149.2005. PMC 1235851. PMID 16189015.
  12. ^ Whitehouse ER, Rao AK, Yu YC, et al. Novel Treatment of a Vaccinia Virus Infection from an Occupational Needlestick — San Diego, California, 2019. MMWR Morb Mortal Wkly Rep 2019;68:943–946. DOI:10.15585/mmwr.mm6842a2
  13. ^ a b "Tecovirimat SIGA: Pending EC decision". European Medicines Agency. 11 November 2021. Retrieved 13 November 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

External links[]

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