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Efficacy of VERQUVO® (vericiguat)

In the VICTORIA study, VERQUVO® (vericiguat) plus background therapy was more effective than background therapy alone in reducing the risk of HF hospitalization and CV death in patients following a worsening HF event.

Primary composite endpoint results for CV death or HFHa

10% RRR for VERQUVO plus background therapy vs placebo plus background therapy (HR=0.90 [95% CI: 0.82−0.98] p=0.019) b,c,d

Data Showing Efficacy of VERQUVO Plus Background Therapy Versus Placebo and Background Therapy

See study design below

VERQUVO showed a superior annualized ARRf of 4.2% compared to placebo for cardiovascular (CV) death or HFH

4.2% Annualized Absolute Risk Reduction With a Number Needed to Treat of 24 for 1 Year to Prevent 1 Event

aFor patients with multiple events, only the first event contributing to the composite endpoint is counted.

bHR (VERQUVO over placebo) and CI from a Cox proportional hazards model.

cFrom the log-rank test.

dBackground therapy included beta blocker, ACE inhibitor, ARB, MRA, ARNI, or SGLT2 inhibitor.

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

fARR, calculated as difference (placebo – VERQUVO) in event rate per 100 patient years.

Study design

VICTORIA was a Phase 3, randomized, parallel-group, placebo-controlled, double-blind, event-driven, multicenter trial comparing VERQUVO to placebo when added to background HF therapy in 5,050 adult patients with NYHA class II-IV chronic HF and LVEF <45% following a worsening HF event (defined as HF hospitalization within 6 months before randomization or use of outpatient IV diuretics for HF within 3 months before randomization). Patients were treated up to the target maintenance dose of VERQUVO 10 mg once daily or matching placebo. The primary endpoint was a composite of time to first event of CV death or HF hospitalization.1

Definitions:

ACE = angiotensin-converting enzyme; ARB = angiotensin II receptor blocker; ARNI = combination of an angiotensin receptor and neprilysin inhibitor; ARR = absolute risk reduction; CI = confidence interval; CV = cardiovascular; HFH = heart failure hospitalization; HR = hazard ratio; LVEF = left ventricular ejection fraction; MRA = mineralocorticoid receptor antagonist; N = number of patients in Intent-to-Treat (ITT) population; n = number of patients with an event; NNT = number needed to treat; NYHA = New York Heart Association; RRR = relative risk reduction; SGLT2 = sodium glucose co-transporter 2; VICTORIA = Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction.

Reference:

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.

Indication

VERQUVO® (vericiguat) tablets 2.5 mg, 5 mg, 10 mg 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.
  • There is a Pregnancy Surveillance Program that monitors pregnancy outcomes in women exposed to VERQUVO during pregnancy. Health care providers should report any prenatal exposure by calling 1-877-888-4231 or at https://pregnancyreporting.verquvo-us.com.
  • 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.

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Indication

VERQUVO® (vericiguat) tablets 2.5 mg, 5 mg, 10 mg 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.
  • There is a Pregnancy Surveillance Program that monitors pregnancy outcomes in women exposed to VERQUVO during pregnancy. Health care providers should report any prenatal exposure by calling 1-877-888-4231 or at https://pregnancyreporting.verquvo-us.com.
  • 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.

Indication

VERQUVO® (vericiguat) tablets 2.5 mg, 5 mg, 10 mg 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%.

VERQUVO® (vericiguat) tablets 2.5 mg, 5 mg, 10 mg is indicated to reduce the risk

VERQUVO® (vericiguat) tablets 2.5 mg, 5 mg, 10 mg 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.
  • There is a Pregnancy Surveillance Program that monitors pregnancy outcomes in women exposed to VERQUVO during pregnancy. Health care providers should report any prenatal exposure by calling 1-877-888-4231 or at https://pregnancyreporting.verquvo-us.com.
  • 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.

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

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.