Merck Gets FDA Approval for Verquvo

By Robb M. Stewart

Merck & Co. said Wednesday it received approval from U.S. regulators for Verquvo, a treatment to reduce the risk of cardiovascular death and hospitalization from heart failure.

The Food and Drug Administration's okay for Verquvo (vericiguat), a soluble guanylate cyclase stimulator that Merck said is the first treatment for chronic heart failure approved specifically for patients following a hospitalization for heart failure or need for outpatient IV diuretics, was based on the results of a late-stage trial and followed a priority regulatory review.

Verquvo, in 2.5 milligram, 5 mg and 10 mg tablets, is being jointly developed with Bayer AG.

The approval was based on data from a randomized, parallel-group, placebo-controlled, double-blind, event-driven, multi-center clinical trial comparing Verquvo to placebo in 5,050 adult patients with symptomatic chronic heart failure and left ventricular ejection fraction less than 45%, following a worsening heart failure event, the company said. It said Verquvo was superior to placebo in reducing the risk of cardiovascular death or heart failure hospitalization based on a time-to-event analysis.

Merck has the commercial rights to vericiguat in the U.S. and Bayer has the exclusive commercial rights in the rest of world. The companies share equally the costs of the development of vericiguat.

Write to Robb M. Stewart at [e-mail]

(END) Dow Jones Newswires

January 20, 2021 07:33 ET (12:33 GMT)

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