The FDA on Jan. 20 approved Verquvo, a soluble guanylate cyclase stimulator developed by Merck and Bayer.
Clinical trial data showed it reduced the risk of cardiovascular death and heart failure following hospitalization or the need for outpatient intravenous diuretics in adults with chronic heart failure and ejection fraction less than 45 percent, according to the company.
The FDA's decision marks the first time the agency has approved a treatment for chronic heart failure specifically for patients following a hospitalization for heart failure or need for outpatient IV diuretics.
Verquvo 2.5 mg, 5 mg and 10 mg tablets are being jointly developed by Merck and Bayer. Merck owns commercial rights to Verquvo in the U.S., with Bayer having exclusive commercial rights in the rest of the world. The two drugmakers have partnered to develop soluble guanylate cyclase modulators since October 2014.
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