dm+d

39976211000001104

New Medicines

Verquvo Heart failure with reduced ejection fraction

Information

Verquvo
New molecular entity
Bayer
Bayer

Development and Regulatory status

Launched
Approved (Licensed)
Approved (Licensed)
August 2021
Aug 21Verquvo oral tablets available in the UK. Price for 28 tablets = £91.56 [17].
Aug 21Bayer confirms it has no plans to launch Verquvo commercially in the UK, but will make it available for individual patients as necessary (presume IFR approval will be needed) [16].
Jul 21Licensed in the UK for treatment of symptomatic chronic heart failure in adults with reduced ejection fraction who are stabilised after a recent decompensation event requiring IV therapy [15].
Jul 21Approved in EU [14].
May 21Recommended for EU approval by CHMP on basis of an assessment by the Committee for Advanced Therapies – the full indication is ‘Verquvo is indicated for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilised after a recent decompensation event requiring IV therapy’. Verquvo will be available as 2.5-mg, 5-mg and 10-mg film-coated tablets [13].
Jan 21Company decides vericiguat will not be launched commercially in the UK [12].
Jan 21Approved in US [11]
Jul 20FDA has granted a priority review for vericiguat. PDUFA date has been agreed for January 2021 [10].
Jun 20Bayer announces the submission of a regulatory application to the EU seeking the approval of vericiguat for patients with symptomatic heart failure with ejection fraction <45% or who have had a previous heart failure event [9].

Category

Stimulator of soluble guanylate cyclase (sGC) enzyme
1-2% of the population have heart failure which rises with age. Prevalence is around 10% in those aged 70 [2]. Approximately 50% of those with heart failure have reduced ejection fraction [1].
Heart failure with reduced ejection fraction
Oral

Further information

Yes

Trial or other data

Mar 20PIII VICTORIA RCT (n=5050) is published; it found a lower risk of death from cardiovascular causes or hospitalisation for heart failure with vericiguat vs placebo at median 10.8 months (35.5% vs 38.5%, HR 0.90, 95% CI 0.82-0.98) [8].
Nov 19Topline results from PIII VICTORIA trial indicate that vericiguat (in combination with other heart failure treatments) met the primary endpoint by demonstrating a statistically significant reduction of the first occurrence of a composite of cardiovascular death or heart failure hospitalisation vs. placebo in >5000 pts with CHF with reduced ejection fraction (HFrEF).[7]
Mar 17Results of PIIb 12 week dose-finding study, SOluble guanylate Cyclase stimulatoR in heArT failurE patientS with PRESERVED EF (SOCRATES-PRESERVED), show that vericiguat was well tolerated, did not change N-terminal pro-B-type natriuretic peptide or left atrial volume at 12 weeks vs. placebo, but was linked to improvements in QoL [5].
Oct 16PIII VICTORIA trial (NCT02861534) is expected to complete collection of primary outcome data in Jan 2020. Patients are currently being recruited in Israel [3].
Oct 16Recruitment to the PIII VICTORIA trial is also underway in Germany, Hungary and Spain, and is expected to expand to other EU countries and the US, plus other countries [4].
Sep 16PIII trial (´VICTORIA´) started that will assess the efficacy and safety of vericiguat up to 10 mg once daily in reducing the risk of cardiovascular death or HF hospitalization in patients with reduced ejection fraction following HF hospitalization or receiving an intravenous diuretic without hospitalization. The primary efficacy outcome is the time to first occurrence of the composite endpoint of cardiovascular mortality or HF hospitalization. The trial is expected to last 39 months [1].

Evidence based evaluations