European Commission (Ec) Grants Marketing Authorization in the European Union (Eu) for Merck & Co., Inc.' Soluble Guanylate Cyclase Stimulator Verquvo
July 21, 2021 at 07:14 am EDT
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Merck announced that the European Commission (EC) has granted marketing authorization in the European Union (EU) for soluble guanylate cyclase (sGC) stimulator VERQUVO® (vericiguat). In the EU, VERQUVO (2.5 mg, 5 mg, and 10 mg) is indicated for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilized after a recent decompensation event requiring intravenous (IV) therapy. VERQUVO is being jointly developed by Merck and Bayer AG. Merck has the commercial rights to VERQUVO in the United States and Bayer has the exclusive commercial rights in the rest of world.
In January of this year, the U.S. Food and Drug Administration (FDA) approved VERQUVO in the U.S. to reduce the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%. In the U.S., the product label for VERQUVO contains a boxed warning that indicates that VERQUVO should not be administered to pregnant females because it may cause fetal harm. For more information, see “Selected Safety Information” below. In June, the medicine was approved by the Ministry of Health, Labour, and Welfare (MHLW) in Japan. Bayer has also submitted applications for marketing authorization of the medicine in China as well as multiple other countries worldwide.
VERQUVO is a stimulator of soluble guanylate cyclase (sGC), an important enzyme in the nitric oxide (NO) signaling pathway. When NO binds to sGC, the enzyme catalyzes the synthesis of intracellular cyclic guanosine monophosphate (cGMP), a second messenger that plays a role in the regulation of vascular tone, cardiac contractility, and cardiac remodeling. Heart failure is associated with impaired synthesis of NO and decreased activity of sGC, which may contribute to myocardial and vascular dysfunction. By directly stimulating sGC, independently of and synergistically with NO, vericiguat augments levels of intracellular cGMP, leading to smooth muscle relaxation and vasodilation.
Merck & Co., Inc. specializes in the development, production, and marketing of therapeutic products and vaccines sold under prescription. Net sales break down by activity as follows:
- sale of pharmaceutical products (69.7%): for treating hypertension, osteoporosis, atherosclerosis, respiratory, bacterial and fungal, ophthalmologic, and urological diseases, acute migraine, hair loss in men, etc.;
- sale of vaccines (18%);
- sale of animal health products (9.4%);
- other (2.9%).
Net sales are distributed geographically as follows: the United States (45.9%), Europe/Middle East/Africa (24.5%), China (8.8%), Japan (6.1%), Asia/Pacific (6.1%), Latin America (4.3%) and other (4.3%).
MERCK & CO., INC. 
