WuXi PharmaTech Content Team Report
On May 19, the official website of the China National Medical Products Administration (NMPA) announced that the innovative therapy vericiguat (vericiguat, an English product jointly developed by Bayer and Merck & Co., Ltd.) Verquvo) has been approved for marketing through priority review and is indicated for patients with stable reduced ejection fraction (EFF) in stable condition after recent decompensated heart failure decompensation therapy, in order to reduce the incidence of heart failure hospitalization or heart failure. Risk of needing emergency intravenous diuretic therapy. vericiguat is the first direct stimulator of soluble guanylate cyclase, according to an earlier Bayer press release.
Screenshot source: NMPA official website
Vericiguat is an oral once-daily direct water-soluble guanylate cyclase (sGC) agonist. sGCs are important for both vascular and cardiac function, however, sGCs are not fully activated in patients with heart failure, resulting in abnormal myocardial and vascular function. Vericiguat restores the function of a key signaling pathway (NO-sGC-cGMP) by activating sGC. In May 2014, Bayer and Merck reached a research and development agreement to jointly develop and promote vericiguat. In January 2021, the drug was approved for marketing in the United States for the treatment of symptomatic chronic heart failure patients with an ejection fraction of less than 45% after experiencing a worsening event of heart failure.
In China, Bayer announced in August 2020 that the NDA for vericiguat tablets was accepted by the China National Medical Products Administration Center for Drug Evaluation (CDE) for adults with symptomatic chronic heart failure Patient (ejection fraction
Vericiguat has previously been shown in clinical trials to reduce the risk of cardiovascular death in selected patients with heart failure. In a randomized, double-blind, placebo-controlled, phase 3 VICTORIA study of patients with exacerbation of chronic heart failure, high risk of cardiovascular death, and repeated heart failure hospitalizations, 5050 subjects were included strong>, the primary end point was the composite event of cardiovascular death or first heart failure hospitalization.
At a median follow-up of 10.8 months, the vericiguat group had a 4.2% absolute reduction in absolute risk (ARR) for the primary end point, strong>Clinically significant, Number needed to treat (NNT) was 24, equivalent to 1 reduction of the primary end point event for every 24 patients treated. For the secondary endpoint, the re-hospitalization rate for heart failure was significantly lower in the vericiguat group than in the placebo group (27.4% vs. 29.6%), with no significant difference in the other endpoints. At the same time, vericiguat also showed good safety and tolerability. The VICTORIA study results have been published in the New England Journal of Medicine.
Screenshot source: Reference [4]
Bayer has stated in a press release that vericiguat is the first drug targeting the NO-sGC-cGMP pathway to achieve positive results in the treatment of heart failure. For patients with chronic heart failure, especially those with worsening heart failure, it will be a new drug treatment method in addition to the current standard treatment and mechanism, which can further improve the clinical outcomes of patients with heart failure.
Public data shows that patients with chronic heart failure will experience a cycle of “heart failure worsening – stable disease – worsening heart failure”. The risk of hospitalization and cardiovascular death was significantly elevated. However, there is currently no specific drug treatment for this patient group, and there is a large unmet clinical need. It is hoped that the approval of vericiguat in China will bring new treatment options to more heart failure patients.
References:
[1] NMPA approves the listing of Verixiguat tablets. Retrieved May 19 , 2022. from https:https://www.nmpa.gov.cn/yaowen/ypjgyw/ 20220519135816168.html
[2]U.S. FDA approves vericiguat for patients with symptomatic chronic heart failure. Retrieved January 20, 2021, from https:https://media.bayer.com/baynews/baynews.nsf/ id/US-FDA-approves-vericiguat-for-patients-with-symptomatic-chronic-heart-failure?OpenDocument&sessionID=1652245209
[3] Bayer submits a marketing authorization application for Vericiguat in the treatment of symptomatic chronic heart failure in China. Retrieved Sep 28, 2020, from https:https://www.bayer.com.cn/index .php/NewsCenter/newsDetail/id/585
[4]Paul W. Armstrong, Burkert Pieske, Kevin J. Anstrom, et al. Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction. DOI: 110.1056/NEJMoa1915928
[5]Boettcher M, Gerisch M, Lobmeyer M, et al. Metabolism and Pharmacokinetic Drug-Drug Interaction Profile of Vericiguat, A Soluble Guanylate Cyclase Stimulator: Results From Preclinical and Phase I Healthy Volunteer Studys. Clin Pharmacokinet. 2020;59(11):1407-1418. doi:10.1007/s40262-020-00895-x
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