Vericiguat
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Trade names | Verquvo |
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Routes of administration | By mouth |
Drug class | Soluble guanylate cyclase activator |
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ECHA InfoCard | 100.247.370 |
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Formula | C19H16F2N8O2 |
Molar mass | 426.388 g·mol−1 |
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Vericiguat, sold under the brand name Verquvo, is a medication used to reduce the risk of cardiovascular death and heart failure.[2][3][4] It is taken by mouth.[2][3][4]
Common side effects include low blood pressure and low red cell count (anemia).[3][4]
Vericiguat is a soluble guanylate cyclase (sGC) stimulator.[2] It was approved for medical use in the United States in January 2021,[3][5] and for use in the European Union in July 2021.[4]
Medical uses
Vericiguat is indicated to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45%.[2][3]
Adverse effects
Vericiguat causes harm to the unborn baby and should not be given to pregnant women.[3]
History
The U.S. Food and Drug Administration (FDA) approved vericiguat based on evidence from a clinical trial (NCT02861534) which consisted of 5,050 participants aged 23 to 98 years old with worsening heart failure.[3] The trial was conducted at 694 sites in 42 countries in Europe, Asia, North and South America.[3] The trial enrolled participants with symptoms of worsening heart failure.[3] Participants were randomly assigned to receive vericiguat or a placebo pill once a day.[3] Neither the participants nor the health care professionals knew if the participants were given vericiguat or placebo pill until after the trial was complete.[3]
Society and culture
Legal status
On 20 May 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 for vericiguat, intended for the treatment of symptomatic chronic heart failure in adults with reduced ejection fraction.[6] The applicant for this medicinal product is Bayer AG. Vericiguat was approved for medical use in the European Union in July 2021.[4]
References
- 1 2 "Verquvo". Therapeutic Goods Administration (TGA). 29 November 2021. Retrieved 28 December 2021.
- 1 2 3 4 5 6 "Verquvo- vericiguat tablet, film coated". DailyMed. Retrieved 9 February 2021.
- 1 2 3 4 5 6 7 8 9 10 11 12 "Drug Trials Snapshot: Verquvo". U.S. Food and Drug Administration (FDA). 8 February 2021. Retrieved 8 February 2021. This article incorporates text from this source, which is in the public domain.
- 1 2 3 4 5 6 "Verquvo EPAR". European Medicines Agency (EMA). 19 May 2021. Retrieved 14 September 2021.
- ↑ "Drug Approval Package: Verquvo". U.S. Food and Drug Administration (FDA). 17 February 2021. Retrieved 14 September 2021.
- ↑ "Verquvo: Pending EC decision". European Medicines Agency. 20 May 2021. Retrieved 23 May 2021. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
Further reading
- Armstrong PW, Pieske B, Anstrom KJ, Ezekowitz J, Hernandez AF, Butler J, et al. (May 2020). "Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction". N Engl J Med. 382 (20): 1883–1893. doi:10.1056/NEJMoa1915928. PMID 32222134.
External links
- "Vericiguat". Drug Information Portal. U.S. National Library of Medicine.
- Clinical trial number NCT02861534 for "A Study of Vericiguat in Participants With Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-001) (VICTORIA)" at ClinicalTrials.gov