VERQUVO®

(vericiguat) tablets 2.5 mg, 5 mg, 10 mg

VICTORIA is the first positive outcome study focusing specifically on high-risk HFrEF patients following an HF hospitalization or outpatient IV diuretic use

VICTORIA: Key characteristics

Phase 3, randomized, parallel-group, placebo-controlled, double-blind, event-driven, multicenter trial1

Compared VERQUVO to placebo, both added on to standard of care HF therapies

  • Primary endpoint was a composite of time to CV death or HF hospitalization
  • Patients were treated up to the target maintenance dose of VERQUVO 10 mg once daily or matching placebo

Median follow-up was 11 months

Included 5,050 adult patients with HFrEF:

  • 84% had an HF hospitalization within 6 months of enrollment
  • 16% had been treated with outpatient IV diuretics within 3 months of enrollment
  • High NT-proBNP levels: Median NT-proBNP=2,800 pg/mL2
  • Low mean eGFR: 62 mL/min/1.73 m2 2
    • - 12% of patients had an eGFR between 15 and 30 mL/min/1.73 m2
    • - VERQUVO was not studied in patients with eGFR <15 mL/min/1.73 m2 at treatment initiation or who were on dialysis
  • Patients were well treated: 91% of patients were treated with 2 or more HF medications
  • LVEF <45%

Primary composite endpoint of CV death or HFH: Event rate (% of patients per year)a

37.8 % Of patients per year in the placebo arm of the VICTORIA study, who were on guideline-recommended therapies, experienced an HF hospitalization or CV death

Among these patients, guideline-recommended therapies included beta blockers, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), mineralocorticoid receptor antagonists (MRAs), combination of an angiotensin receptor and neprilysin inhibitor (ARNI), or sodium glucose co-transporter 2 (SGLT2) inhibitors.

aTotal patients with an event per 100 patient years at risk.

CV = cardiovascular; eGFR = estimated glomerular filtration rate; HF = heart failure; HFH = heart failure hospitalization; HFrEF = heart failure with reduced ejection fraction; IV = intravenous; LVEF = left ventricular ejection fraction; NT-proBNP = N-terminal prohormone B-type natriuretic peptide; VICTORIA = Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction.

References:

1. Armstrong PW, Pieske B, Anstrom KJ, et al. Vericiguat in patients with heart failure and reduced ejection fraction. N Engl J Med. 2020;382(20):1883-1893.

2. Pieske B, Patel MJ, Westerhout CM, et al; on behalf of the VICTORIA Study Group. Baseline features of the VICTORIA (Vericiguat Global Study in Subjects with Heart Failure with Reduced Ejection Fraction) trial. Eur J Heart Fail. 2019;21(12):1596-1604.

Indications and Usage

VERQUVO is indicated to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for HF or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45%.

Selected Safety Information

WARNING: EMBRYO-FETAL TOXICITY

Females of reproductive potential: Exclude pregnancy before the start of treatment. To prevent pregnancy, females of reproductive potential must use effective forms of contraception during treatment and for one month after stopping treatment. Do not administer VERQUVO to a pregnant female because it may cause fetal harm.

  • VERQUVO is contraindicated in patients with concomitant use of other soluble guanylate cyclase (sGC) stimulators.

  • VERQUVO is contraindicated in pregnancy.

  • Embryo-Fetal Toxicity: Based on data from animal reproduction studies, VERQUVO may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to a fetus. Obtain a pregnancy test before the start of treatment. Advise females of reproductive potential to use effective contraception during treatment with VERQUVO and for at least one month after the final dose.

  • In a clinical trial, the most commonly observed adverse events with VERQUVO vs placebo, occurring at a frequency ≥5%, were hypotension (16% vs 15%) and anemia (10% vs 7%).

  • Concomitant use of VERQUVO with PDE-5 inhibitors is not recommended due to the potential for hypotension.

  • There are no data on the presence of vericiguat in human milk, the effects on the breastfed infant, or effects on milk production. Because of the potential for serious adverse reactions in breastfed infants from VERQUVO, advise women not to breastfeed during treatment with VERQUVO.

Before prescribing VERQUVO, please read the accompanying Prescribing Information, including the Boxed Warning about embryo-fetal toxicity. The Medication Guide also is available.

US-VER-0095008/21