VERQUVO®

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

Efficacy

In the VICTORIA study, VERQUVO® (vericiguat) was superior to placebo in reducing the risk of CV death or HFH based on a time-to-event analysis

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

Primary Composite Endpoint Results for VERQUVO® (vericiguat) Compared to Placebo Primary endpoint VERQUVO n (%) Composite of CV death or HF hospitalizations a 897 (35.5) 0 20 10 30 40 Event rate (% pt-yr) e Placebo n (%) 972 (38.5) 37.8 % n=972 33.6 % n=897 Background therapy d + Placebo N=2,524 Background therapy d + VERQUVO N=2,526

VERQUVO showed a superior annualized ARR of 4.2% compared to placebo for CV death or HFH

4.2 % annualized ARR f NNT o f 24 For 1 year to prevent 1 event The effect ofVERQUVO reflectsa reduction in CVdeath and HFH

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, or a combination of an ARNI.

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

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

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; 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; RRR = relative risk reduction; VICTORIA = Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction

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