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Merck, Bayer get FDA priority review for heart failure drug

Target action date set for January 2021

Merck

Merck and Bayer’s high-risk heart failure drug vericiguat has scored a priority review from the US Food and Drug Administration (FDA), four years after the partners took a gamble on the drug when it yielded mixed results in a phase 2 trial.

In the mid-stage SOCRATES-REDUCED trial, vericiguat given at a range of doses failed to achieve its primary objective of reducing N-terminal pro-B-type natriuretic peptide (NT-proBNP), a biomarker in patients with worsening chronic heart failure with reduced ejection fraction (HFrEF).

However, according to the investigators in the trial, in a subgroup of patients given the highest dose (10mg), vericiguat showed some improvements in left ventricular ejection fraction (LVEF) as well as fewer clinical events compared to the placebo group.

Despite the mixed results, Merck and Bayer decided to take their chances and advanced the vericiguat clinical programme into phase 3. In March, the partners revealed the results from the 5,050-patient VICTORIA study, in which vericiguat demonstrated a 10% reduction in the rate of cardiovascular deaths and hospitalisations among HFrEF patients compared to placebo.

After close to 11 months follow-up, 35.5% of the vericiguat treatment group and 38.5% of the placebo group hit the primary endpoint, with most of the benefit coming from a reduction in hospitalisations for heart failure. Even though the drug reduced hospitalisation, the difference in cardiovascular death and all-cause mortality between the groups was not significantly different.

Some cardiologists took issue with the results from this study, in particular when compared to other recently approved cardiovascular drugs. That includes Novartis’ Entresto (sacubitril/valsartan), which demonstrated 20% overall reduction in deaths or hospitalisations, and AstraZeneca’s Farxiga/Forxiga (dapagliflozin) which had a 26% improvement in cardiovascular death and worsening heart failure compared to placebo in the DAPA-HF trial.

Although doubts can be raised around vericiguat’s strength in relation to other drugs in the heart failure setting,  it is not always a helpful or a robust way of determining benefit to compare different clinical studies. It’s also worth keeping in mind that Farxiga/Forxiga was tested in a less sick patient population, and having multiple therapeutic options is always a good thing for patients and clinicians.

With the FDA priority review in their pocket, Merck and Bayer can expect a decision by 20 January 2021. The New Drug Application (NDA) filed for vericiguat is aiming for approval as a treatment to reduce the risk of cardiovascular death and heart failure hospitalisation following a worsening heart failure event in patients with HFrEF, in combination with other heart failure therapies.

Article by
Lucy Parsons

17th July 2020

From: Regulatory

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