Earlier this week, the FDA approved Bayer and Merck & Co.'s Verquvo as a new therapy designed to reduce the risk of cardiovascular death and hospitalisation in some heart failure patients. This market has seen notable activity in recent years, following the launch of Novartis' Entresto and the accumulation of compelling data for SGLT-2 inhibitors (initially developed for the treatment of type 2 diabetes).
As we wrote here, Phase III data for Verquvo may put the onus on Bayer and Merck to convince physicians that the drug – a soluble guanylate cyclase (SGC) modulator – deserves a foothold in the rapidly evolving treatment algorithm for heart failure. Merck told FirstWord that Verquvo can play an important role in the treatment of severely compromised patients, where the need for additional therapeutic options is greatest.
To get a better understanding of how Verquvo may be used, we are fielding a short Physician Views survey to US cardiologists, with results published later this week. Specifically we are asking them…
Q. The FDA approved Verquvo (vericiguat) to reduce the risk of cardiovascular death and heart failure (HF) hospitalisation in certain adults with symptomatic chronic HF and ejection fraction less than 45%. Verquvo (a sGC stimulator) is the first chronic HF treatment specifically indicated for patients following a hospitalisation for HF or need for outpatient intravenous diuretics.
Taking into account other available therapies, how would you describe the level of unmet need for this particular cohort of patients?
1 – None 2 3 4 5 6 7 – Very high
Q. Approval of Verquvo is based on Phase III data from the VICTORIA study involving 5050 symptomatic chronic HF patients with reduced left ventricular ejection fraction of less than 45%. The primary efficacy objective was to determine whether Verquvo was more effective than placebo, both in combination with other HF therapies, at cutting the risk of cardiovascular death or hospitalisation due to HF in patients following a worsening HF event.
Data presented last year at the American College of Cardiology's (ACC) annual scientific sessions showed that Verquvo met the primary efficacy objective based on a time-to-event analysis, demonstrating a 4.2% reduction in annualised absolute risk versus placebo. The results indicate that 24 patients would need to be treated over an average of one year to prevent one primary endpoint event.
The primary outcome event, defined as a composite of death from cardiovascular causes or first HF-related hospitalisation, occurred in 35.5% of patients in the Verquvo group versus 38.5% in the placebo group over a median of 10.8 months of follow-up.
HF-related hospitalisation occurred in 27.4% of patients given Verquvo, compared to 29.6% in the placebo arm, while cardiovascular death occurred in 16.4% and 17.5% of subjects in the two groups, respectively.
Do you consider these data to be impressive?
1 – Not at all impressive 2 3 4 5 6 7 – Very impressive
Q. Following its approval and taking into account the availability of other relatively new available HF treatments, do you anticipate prescribing Verquvo over the next 12 months?
Q. In terms of peak use, what percentage of eligible HF patients (as per recommended use) do you anticipate prescribing Verquvo to?
Q. Verquvo's developers suggest that many HF patients continue to decompensate every year requiring hospitalisation or outpatient intravenous therapy with diuretics and face a worsening prognosis over time. Developed to be used immediately after a HF patient experiences a 'clinical trigger,' Verquvo could carve out specific use in more severely compromised patients, they argue.
Do you agree with this assessment?
Neither agree nor disagree
Results and related analysis will shortly be published for FirstWord Pharma PLUS subscribers to read, with the opportunity for non-FirstWord Pharma PLUS subscribers to purchase these findings. To be notified when poll results and analysis become available, please click here
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