Merck's NDA for Heart Failure Candidate Gets Priority Review

Merck & Co., Inc. MRK announced that the FDA has accepted and granted priority review to the new drug application (“NDA”) for its orally soluble guanylate cyclase (sGC) stimulator, vericiguat. The NDA is seeking approval for vericiguat in combination with other therapies to reduce the risk of cardiovascular death and heart failure following a worsening heart failure event in patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF).

A decision related to approval of the NDA is expected by Jan 20, 2021 from the FDA. Please note that Merck has developed the candidate in collaboration with its Germany-based partner Bayer BAYRY.

The NDA was filed based on positive data from the phase III contemporary outcomes study — VICTORIA. Data from the study, announced last year, showed that vericiguat reduced the risk of composite endpoint of heart failure hospitalization or cardiovascular death in such patients compared to placebo.

Merck’s shares have declined 12.6% this year so far against the industry’s increase of 1.2%.

Heart failure affects more than 60 million patients globally. Despite huge progress made on addressing this disease, the cardiovascular event rates are high, creating a huge unmet need for new therapies to reduce the risk of death and hospitalizations. In the United States, currently 6.5 million people suffer heart failure and approximately 40-50% of these have HFrEF, per the press release. Such patients frequently experience deterioration of the disease and an estimated one in five patients with worsening chronic HFrEF expires within two years.

Novartis’ NVS Entresto is approved to treat HFrEF. Amgen AMGN and partner Cytokinetics’s pipeline candidate omecamtiv mecarbil is in late-stage development for HFrEF. AstraZeneca’s SGLT2 inhibitor Farxiga was approved for treating HFrEF in May 2020.

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Merck currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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